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Clinical Trials/NCT06269107
NCT06269107
Completed
Phase 3

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

Novo Nordisk A/S189 sites in 4 countries485 target enrollmentStarted: February 15, 2024Last updated:
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ConditionsType 2 Diabetes
InterventionsIcoSemaInsulin glargine
DrugsIcoSemaInsulin glargine

Overview

Phase
Phase 3
Status
Completed
Enrollment
485
Locations
189
Primary Endpoint
Change in glycated haemoglobin (HbA1c)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.
  • •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

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.

Arms & Interventions

IcoSema

Experimental

Participants will receive once weekly IcoSema subcutaneously with or without oral anti diabetic drugs for 40 weeks.

Intervention: IcoSema (Drug)

Insulin glargine

Experimental

Participants will receive once daily insulin glargine subcutaneously with or without oral anti diabetic drugs for 40 weeks.

Intervention: Insulin glargine (Drug)

Outcomes

Primary Outcomes

Change in glycated haemoglobin (HbA1c)

Time Frame: From baseline (week 0) to week 40

Measured in percentage (%)-point.

Secondary Outcomes

  • Time spent greater than (>) 10.0 mmol/L (180 mg/dL)(From week 36 to week 40)
  • Change in body weight(From baseline (week 0) to week 40)
  • Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL])(From week 36 to week 40)
  • Time spent less than (<) 3.0 mmol/L (54 mg/dL)(From week 36 to week 40)
  • Weekly basal insulin dose(From week 38 to week 40)
  • Change in fasting plasma glucose (FPG)(From baseline (week 0) to week 40)
  • Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)(From baseline (week 0) to week 45)
  • Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction(From baseline (week 0) to week 40)
  • 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)(From baseline (week 0) to week 45)
  • Number of severe hypoglycaemic episodes (level 3)(From baseline (week 0) to week 45)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (189)

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