EUCTR2020-005308-21-HUActive, not recruitingPhase 1
A 52 week study comparing the efficacy and safety of once weekly IcoSema and once weekly semaglutide, both treatment arms with or without oral anti diabetic drugs, in participants with type 2 diabetes inadequately controlled with a GLP 1 receptor agonist. COMBINE 2 - COMBINE 2
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 680
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Male or female and age above or equal to 18 years at the time of signing informed consent.
- •- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
- •- HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- •- Insulin naïve. The following exceptions are permitted: short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes.
- •- Treated with stable doses of daily or weekly GLP 1 receptor agonist (excluding once weekly semaglutide with doses higher than 1.0 mg) according to local label for the treatment of diabetes greater than or equal to 90 days before screening. The treatment can be with or without any of the following anti diabetic drugs with stable doses greater than or equal to 90 days before screening:
- •Metformin
- •Sulfonylureas (a)
- •Meglitinides (glinides) (a)
- •DPP 4 inhibitors (a)
- •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 kg/m^2.
- •(a) Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 612
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
Exclusion Criteria
- •- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a 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).
- •- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- •- Any episodes( as declared by the participant or in the medical records ) of diabetic ketoacidosis 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.
- •- 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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A research study to see how well the new weekly medicine IcoSema, which is a combination of insulin icodec and semaglutide, controls blood sugar level in people with type 2 diabetes compared to weekly semaglutide (COMBINE 2)Diabetes Mellitus, Type 2EUCTR2020-005308-21-SKovo Nordisk A/S680
Active, not recruiting
Phase 1
A research study to see how well the new weekly medicine IcoSema, which is a combination of insulin icodec and semaglutide, controls blood sugar level in people with type 2 diabetes compared to weekly semaglutide (COMBINE 2)MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2020-005308-21-GRovo Nordisk A/S680
Active, not recruiting
Phase 1
A research study to see how well the new weekly medicine IcoSema, which is a combination of insulin icodec and semaglutide, controls blood sugar level in people with type 2 diabetes compared to weekly insulin icodec (COMBINE 1)Diabetes Mellitus, Type 2EUCTR2020-005281-34-BGovo Nordisk A/S1,290
Completed
Phase 3
A research study to see how well the new weekly medicine IcoSema, which is a combination of insulin icodec and semaglutide, controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken daily with insulin aspart (COMBINE 3)CTRI/2022/01/039705ovo Nordisk90
Active, not recruiting
Phase 1
A research study to see how well the new weekly medicine IcoSema, which is a combination of insulin icodec and semaglutide, controls blood sugar level in people with type 2 diabetes compared to weekly insulin icodec (COMBINE 1)Diabetes Mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2020-005281-34-HRovo Nordisk A/S1,290