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A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight (REDEFINE 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: NCT05394519
Recruitment Status : Active, not recruiting
First Posted : May 27, 2022
Last Update Posted : November 29, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance.

The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.


Condition or disease Intervention/treatment Phase
Overweight Obesity Type 2 Diabetes Mellitus Drug: Cagrilintide Drug: Semaglutide Drug: Placebo cagrilintide Drug: Placebo semaglutide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes
Actual Study Start Date : February 1, 2023
Estimated Primary Completion Date : December 11, 2024
Estimated Study Completion Date : January 29, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: CagriSema
Cagrilintide + semaglutide once weekly
 Drug: Cagrilintide
Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

Drug: Semaglutide
Semaglutide administered subcutaneously (s.c., under the skin) once-weekly
Placebo Comparator: Placebo
Placebo cagrilintide + semaglutide once weekly
 Drug: Placebo cagrilintide
Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

Drug: Placebo semaglutide
Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly


Outcome Measures
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Primary Outcome Measures :
  1. Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in percentage (%).

  2. Achievement of greater than or equal to (≥) 5% weight reduction [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Count of participant.


Secondary Outcome Measures :
  1. Achievement of ≥ 20% weight reduction [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Count of participant.

  2. Relative change in body weight [ Time Frame: From baseline (week 0) to week 20 ]
    Measured in %.

  3. Change in waist circumference [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in centimeter (cm).

  4. Change in Glycated Haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in %-points.

  5. Change in Systolic Blood Pressure (SBP) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in millimeter of mercury (mmHg).

  6. Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in score points.

  7. Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in score points.

  8. Change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in kilogram (kg).

  9. Change in body mass index (BMI) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in kilogram per meter square (kg/m^2).

  10. Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Count of participant.

  11. Achievement of HbA1c less than or equal to (≤) 6.5% [ Time Frame: At end of treatment (week 68) ]
    Count of participant.

  12. Change in Fasting Plasma Glucose (mmol/L) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in millimoles per liter (mmol/L).

  13. Change in Fasting Plasma Glucose (mg/dL) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in milligram per deciliter (mg/dL)

  14. Ratio to baseline in fasting serum insulin [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in ratio.

  15. Change in Diastolic Blood Pressure (DBP) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in mmHg.

  16. Ratio to baseline in C-reactive protein (CRP) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in ratio.

  17. Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides and Free fatty acids [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in ratio.

  18. Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    IWQOL-Lite-CT is a 20-item clinical outcomes assessment (COA) instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. Score ranges for composite score (physical composite, psychosocial composite and physical function composite) and Total score is 0-100. Higher scores indicate better level of functioning.

  19. Change in Control of Eating Questionnaire (CoEQ): Craving Control score, Positive Mood score, Craving for Sweet score, Craving for Savoury food score, Hunger score and Satiety score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). Higher score represents a greater level of Craving Control.

  20. Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Count of participant.

  21. Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Count of participant.

  22. Change in IWQOL-Lite-CT Physical Function score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
  23. Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Count of participant.

  24. Continuous glucose monitoring: Change in mean glucose (mmol/L) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in mmol/L.

  25. Continuous glucose monitoring: Change in mean glucose (mg/L) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in mg/L.

  26. CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in %-points.

  27. CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in %-points.

  28. CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in %-points.

  29. CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in %-points.

  30. CGM: Within-day glycaemic variability (% CV) [ Time Frame: At end of treatment (week 68) ]
    Measured in %.

  31. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From baseline (week 0) to end of study (week 75) ]
    Count of events.

  32. Number of Treatment Emergent Serious adverse events (TESAEs) [ Time Frame: From baseline (week 0) to end of study (week 75) ]
    Count of events.

  33. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) [ Time Frame: From baseline (week 0) to end of study (week 75) ]
    Count of episodes.

  34. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold [ Time Frame: From baseline (week 0) to end of study (week 75) ]
    Count of episodes.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • Age above or equal to 18 years at the time of signing informed consent
  • BMI greather than or equal to 27.0 kg/m^2
  • Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
  • HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening

Exclusion Criteria:

  • Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
  • Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, as measured by the central laboratory at screening
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05394519


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 2834) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT05394519    
Other Study ID Numbers: NN9838-4609
U1111-1267-4287 ( Other Identifier: World Health Organization (WHO) )
2021-005121-24 ( EudraCT Number )
jRCT2031220671 ( Registry Identifier: jRCT (Japan) )
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: November 29, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight