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Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity (STEP 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552757
Recruitment Status : Completed
First Posted : June 12, 2018
Results First Posted : August 11, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE May 30, 2018
First Posted Date  ICMJE June 12, 2018
Results First Submitted Date  ICMJE June 16, 2021
Results First Posted Date  ICMJE August 11, 2021
Last Update Posted Date November 9, 2021
Actual Study Start Date  ICMJE June 4, 2018
Actual Primary Completion Date March 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo [ Time Frame: Baseline (week 0) to week 68 ]
    Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
  • Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo [ Time Frame: At week 68 ]
    Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • Change in body weight [ Time Frame: Week 0, week 68 ]
    Measured in %
  • Subjects who achieve (yes/no): Body weight reduction greater than or equal to 5% [ Time Frame: Week 0, week 68 ]
    Number of subjects
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg [ Time Frame: Baseline (week 0) to week 68 ]
    Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg [ Time Frame: At week 68 ]
    Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Waist Circumference [ Time Frame: Baseline (week 0) to week 68 ]
    Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Body Weight (Kg) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in BMI [ Time Frame: Baseline (week 0) to week 68 ]
    Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% [ Time Frame: At week 68 ]
    Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% [ Time Frame: At week 68 ]
    Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% [ Time Frame: At week 68 ]
    Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in HbA1c (%) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in HbA1c (mmol/Mol) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in FPG (mg/dL) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Fasting Serum Insulin [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol) [ Time Frame: At week 68 ]
    Number of participants who achieved HbA1c <7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol) [ Time Frame: At week 68 ]
    Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0% [ Time Frame: At week 68 ]
    Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0% [ Time Frame: At week 68 ]
    Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Systolic Blood Pressure [ Time Frame: Baseline (week 0) to week 68 ]
    Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Diastolic Blood Pressure [ Time Frame: Baseline (week 0) to week 68 ]
    Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Total Cholesterol [ Time Frame: Baseline (week 0) to week 68 ]
    Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in HDL Cholesterol [ Time Frame: Baseline (week 0) to week 68 ]
    Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in LDL Cholesterol [ Time Frame: Baseline (week 0) to week 68 ]
    Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in VLDL Cholesterol [ Time Frame: Baseline (week 0) to week 68 ]
    Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Free Fatty Acids [ Time Frame: Baseline (week 0) to week 68 ]
    Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Triglycerides [ Time Frame: Baseline (week 0) to week 68 ]
    Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in hsCRP [ Time Frame: Baseline (week 0) to week 68 ]
    Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in PAI-1 Activity [ Time Frame: Baseline (week 0) to week 68 ]
    Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score) [ Time Frame: Baseline (week 0) to week 68 ]
    SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
  • Change in SF-36 (All Scores Except Physical Functioning) [ Time Frame: Baseline (week 0) to week 68 ]
    SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
  • Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score) [ Time Frame: Baseline (week 0) to week 68 ]
    The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Change in IWQOL-Lite for CT (All Scores Except Physical Function) [ Time Frame: Baseline (week 0) to week 68 ]
    The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
  • Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score [ Time Frame: At week 68 ]
    The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
  • Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score [ Time Frame: At week 68 ]
    The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
  • Number of TEAEs - Semaglutide 2.4 mg Versus Placebo [ Time Frame: Week 0 to week 75 ]
    Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
  • Number of SAEs - Semaglutide 2.4 mg Versus Placebo [ Time Frame: Week 0 to week 75 ]
    Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
  • Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo [ Time Frame: Week 0 to week 75 ]
    Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
  • Change in Pulse - Semaglutide 2.4 mg Versus Placebo [ Time Frame: Baseline (week 0) to week 68 ]
    Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
  • Change in Amylase - Semaglutide 2.4 mg Versus Placebo [ Time Frame: Baseline (week 0) to week 68 ]
    Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
  • Change in Lipase - Semaglutide 2.4 mg Versus Placebo [ Time Frame: Baseline (week 0) to week 68 ]
    Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
  • Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo [ Time Frame: Baseline (week 0) to week 68 ]
    Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • Subjects who achieve (yes/no): Body weight reduction greater than or equal to 10% [ Time Frame: Week 0, week 68 ]
    Number of subjects
  • Subjects who achieve (yes/no): Body weight reduction greater than or equal to 15% [ Time Frame: Week 0, week 68 ]
    Number of subjects
  • Change in waist circumference [ Time Frame: Week 0, week 68 ]
    Measured in centimetre
  • Change in body weight (%) (semaglutide s.c. 2.4 mg once-weekly versus semaglutide s.c. 1.0 mg once-weekly) [ Time Frame: Week 0, week 68 ]
    Measured in %
  • Change in haemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 68 ]
    Measured in %
  • Change in HbA1c [ Time Frame: Week 0, week 68 ]
    Measured in mmol/mol
  • Change in systolic blood pressure [ Time Frame: Week 0, week 68 ]
    Measured in mmHg
  • Change in physical functioning score (short form-36 [SF-36]) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in physical function domain (5-items) score (Impact of weight on quality of Life-lite [IWQoL-Lite] for Clinical Trials [CT]) [ Time Frame: Week 0, week 68 ]
    The IWQoL-Lite for CT is a 20-item modified version of a questionnaire tool designed to assess the weight-related quality of life.
  • Change in body weight [ Time Frame: Week 0, week 68 ]
    Measured in kg
  • Change in body mass index (BMI) [ Time Frame: Week 0, week 68 ]
    Measured in kg/m^2
  • Change in HbA1c (semaglutide s.c. 1.0 mg once-weekly versus semaglutide placebo I/II) [ Time Frame: Week 0, week 68 ]
    Measured in %
  • Change in HbA1c (semaglutide s.c. 1.0 mg once-weekly versus semaglutide placebo I/II) [ Time Frame: Week 0, week 68 ]
    Measured in mmol/mol
  • Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL
  • Change in fasting serum insulin [ Time Frame: Week 0, week 68 ]
    Measured in mIU/L
  • Change in diastolic blood pressure [ Time Frame: Week 0, week 68 ]
    Measured in mmHg
  • Change in total cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL
  • Change in high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL
  • Change in low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL
  • Change in very low density lipoprotein (VLDL) cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL
  • Change in free fatty acids [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL
  • Change in triglycerides [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL
  • Change in high sensitivity C-Reactive Protein [ Time Frame: Week 0, week 68 ]
    Measured in mg/L
  • Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity [ Time Frame: Week 0, week 68 ]
    Measured in AU/mL
  • Change in SF-36 (role-physical score) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 (bodily pain score) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 (general health score) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 (vitality score) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 (social functioning score) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 (role-emotional score) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 (mental health score) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 (physical component summary) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 (mental component summary) [ Time Frame: Week 0, week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in IWQoL-Lite for CT (pain/discomfort domain score) [ Time Frame: Week 0, week 68 ]
    The IWQoL-Lite for CT is a 20-item modified version of a questionnaire tool designed to assess the weight-related quality of life.
  • Change in IWQoL-Lite for CT (psychosocial domain score) [ Time Frame: Week 0, week 68 ]
    The IWQoL-Lite for CT is a 20-item modified version of a questionnaire tool designed to assess the weight-related quality of life.
  • Change in IWQoL-Lite for CT (total score) [ Time Frame: Week 0, week 68 ]
    The IWQoL-Lite for CT is a 20-item modified version of a questionnaire tool designed to assess the weight-related quality of life.
  • Subjects who achieve (yes/no): Responder definition value for SF-36 physical functioning score [ Time Frame: week 0, week 68 ]
    Number of subjects
  • Subjects who achieve (yes/no): Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score [ Time Frame: Week 0, week 68 ]
    Number of subjects
  • Subjects who achieve (yes/no): HbA1c less than 7.0% (53 mmol/mol) [ Time Frame: Week 0, week 68 ]
    Number of subjects
  • Subjects who achieve (yes/no): HbA1c less than or equal to 6.5% (48 mmol/mol) [ Time Frame: Week 0, week 68 ]
    Number of subjects
  • Number of treatment-emergent adverse events (TEAEs) [ Time Frame: From week 0 to week 75 ]
    Number of events
  • Number of serious adverse events (SAEs) [ Time Frame: From week 0 to week 75 ]
    Number of events
  • Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes [ Time Frame: From week 0 to week 75 ]
    Number of events
  • Change in pulse [ Time Frame: Week 0, week 68 ]
    measured in beats per minute
  • Change in amylase [ Time Frame: Week 0, week 68 ]
    measured in U/L
  • Change in lipase [ Time Frame: Week 0, week 68 ]
    measured in U/L
  • Change in calcitonin [ Time Frame: Week 0, week 68 ]
    measured in ng/L
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
Official Title  ICMJE Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes
Brief Summary This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Drug: Semaglutide 1.0 mg
    Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
  • Drug: Semaglutide 2.4 mg
    Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
  • Drug: Placebo I (Semaglutide)
    S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
  • Drug: Placebo II (Semaglutide)
    S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
Study Arms  ICMJE
  • Experimental: Semaglutide 1.0 mg
    Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
    Interventions:
    • Drug: Semaglutide 1.0 mg
    • Drug: Placebo I (Semaglutide)
  • Experimental: Semaglutide 2.4 mg
    Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
    Interventions:
    • Drug: Semaglutide 2.4 mg
    • Drug: Placebo II (Semaglutide)
  • Placebo Comparator: Semaglutide placebo I/II
    Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
    Interventions:
    • Drug: Placebo I (Semaglutide)
    • Drug: Placebo II (Semaglutide)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
1210
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2018)
1200
Actual Study Completion Date  ICMJE May 1, 2020
Actual Primary Completion Date March 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Body Mass Index (BMI) greater than or equal to 27 kg/m^2 '
  • History of at least one self-reported unsuccessful dietary effort to lose body weight
  • Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m^2 (less than 60 ml/min/1.73 m^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Germany,   Greece,   India,   Japan,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   United Arab Emirates,   United Kingdom,   United States
Removed Location Countries Algeria
 
Administrative Information
NCT Number  ICMJE NCT03552757
Other Study ID Numbers  ICMJE NN9536-4374
U1111-1200-8148 ( Other Identifier: World Health Organization (WHO) )
2017-003414-10 ( Other Identifier: European Medicines Agency (EudraCT) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://www.novonordisk-trials.com
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP