Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female aged above or equal to 18 years at the time of signing informed consent. - Diagnosed with T2D 180 days or more prior to the day of screening. - HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis. - Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. - Stable daily dose(s) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose. b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose). - Sulfonylureas - Meglitinides (glinides) - Dipeptidyl peptidase 4 (DPP-4) inhibitors - Sodium-glucose Cotransporter-2 (SGLT2) inhibitors - Thiazolidinedione - Alpha-glucosidase inhibitor - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs)) - Oral or injectable GLP-1-receptor agonists - Body mass index (BMI) equal to or below 40.0 kg/m^2 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 570 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening. - Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. - Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening. - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids). - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with non-insulin anti-diabetic drugs in insulin-naïve subjects with type 2 diabetes (T2D). This includes comparing the difference in change from baseline in glycosylated haemoglobin (HbA1c) between insulin icodec and insulin degludec after 26 weeks of treatment to a non-inferiority limit of 0.3%.;Secondary Objective: To compare parameters of safety with once weekly insulin icodec versus once daily insulin degludec, both in combination with non-insulin anti-diabetic drugs in insulin-naïve subjects with T2D.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline week 0 (V2) to week 26 (V28) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in fasting plasma glucose (FPG) 2. Number of severe hypoglycaemic episodes (level 3) 3. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) 4. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 5. Number of severe hypoglycaemic episodes (level 3) 6. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) 7. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 8. Change in body weight 9. Mean weekly insulin dose;Timepoint(s) of evaluation of this end point: 1. From baseline week 0 (V2) to week 26 (V28) 2.-4. From baseline week 0 (V2) to week 31 (V30) 5.-8. From baseline week 0 (V2) to week 26 (V28) 9. From week 24 (P26) to week 26 (V28) | — |
Countries
Argentina, Austria, Brazil, Canada, China, Czech Republic, Denmark, European Union, France, Mexico, Taiwan, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed