A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4) (COMBINE 4)
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ClinicalTrials.gov Identifier: NCT06269107 |
Recruitment Status :
Recruiting
First Posted : February 21, 2024
Last Update Posted : April 18, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: IcoSema Drug: Insulin glargine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 474 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A 40-week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL in Participants With Type 2 Diabetes Inadequately Controlled on Oral Anti Diabetic Drugs COMBINE 4 |
Actual Study Start Date : | February 15, 2024 |
Estimated Primary Completion Date : | June 5, 2025 |
Estimated Study Completion Date : | July 10, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: IcoSema
Participants will receive once weekly IcoSema subcutaneously with or without oral anti diabetic drugs for 40 weeks.
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Drug: IcoSema
IcoSema will be administered subcutaneously. |
Experimental: Insulin glargine
Participants will receive once daily insulin glargine subcutaneously with or without oral anti diabetic drugs for 40 weeks.
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Drug: Insulin glargine
Insulin glargine will be administered subcutaneously. |
- Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 40 ]Measured in percentage (%)-point.
- Change in body weight [ Time Frame: From baseline (week 0) to week 40 ]Measured in kilogram (kg).
- Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) [ Time Frame: From week 36 to week 40 ]Measured in % of readings.
- Time spent less than (<) 3.0 mmol/L (54 mg/dL) [ Time Frame: From week 36 to week 40 ]Measured in % of readings.
- Time spent greater than (>) 10.0 mmol/L (180 mg/dL) [ Time Frame: From week 36 to week 40 ]Measured in % of readings.
- Weekly basal insulin dose [ Time Frame: From week 38 to week 40 ]Measured in units of insulin.
- Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (week 0) to week 40 ]Measured in mmol/l.
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction [ Time Frame: From baseline (week 0) to week 40 ]The DTSQs items are scored on a 7-point graded response scale ranging from 0 to 6. Score ranges from 0 to 36. Higher scores indicate greater the satisfaction with medication.
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline (week 0) to week 45 ]Measured in number of episodes.
- 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 week 45 ]Measured in number of episodes.
- Number of severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline (week 0) to week 45 ]Measured in number of episodes.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female and age above or equal to 18 years at the time of signing the informed consent.
- Diagnosed with T2D greater than or equal to (≥) 180 days before screening.
- HbA1c ≥ 8.0% (≥ 64.0 millimoles per mole [mmol/mol]) as assessed by central laboratory on the day of screening.
- Insulin naïve. Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes.
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Currently treated with 1-3 oral anti diabetic drug (OADs) with stable daily doses ≥ 90 days before screening comprising any of the following anti diabetic drug(s) at effective or maximum tolerated dose.
- Metformin
- Sulfonylureas
- Meglitinides (glinides)
- Dipeptidyl peptidase (DPP) 4 inhibitors
- Sodium glucose co transporter 2 inhibitors
- Alpha glucosidase inhibitors
- Thiazolidinediones
- Marketed oral combination products only including the products listed above.
- Body mass index (BMI) less than or equal to (≤) 40.0 kilogram per square meter (kg/m^2).
Exclusion Criteria:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbaring potential and not using highly effective contraceptive method.
- Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
- Any episodes of diabetic ketoacidosis or treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
- Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 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.
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): NCT06269107
Contact: Novo Nordisk | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
Study Director: | Clinical Transparency (dept. 2834) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT06269107 |
Other Study ID Numbers: |
NN1535-4988 U1111-1283-8648 ( Other Identifier: World Health Organization (WHO) ) 2022-502484-38-00 ( Other Identifier: European Medicines Agency (EMA) ) |
First Posted: | February 21, 2024 Key Record Dates |
Last Update Posted: | April 18, 2024 |
Last Verified: | April 2024 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Insulin Glargine Hypoglycemic Agents Physiological Effects of Drugs |