Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Insulin icodec 700 units/mL: Insulin icodec 700 units/mL,
subcutaneous, solution for
injection, 3 mL PDS290
pre-filled pen-injector
Control Intervention1: Insulin glargine 100 units/mL:
Sponsors
Novo Nordisk Denmark
Novo Nordisk India
Eligibility
Inclusion criteria
Inclusion criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Male or female. 3. Age above or equal to 18 years at the time of signing informed consent. 4. Diagnosed with T2D >= 180 days prior to the day of screening. 5. HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis. 6. Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, faster acting insulin lispro, insulin glulisine) >= 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses >= 90 days prior to screening: • Metformin • Sulfonylureas • Meglitinides (glinides) • DPP-4 inhibitors • SGLT2 inhibitors • Thiazolidinediones • Alpha-glucosidase inhibitors • Oral combination products (for the allowed individual oral anti-diabetic drugs) • Oral or injectable GLP-1 RAs 7. Body mass index (BMI) <= 40.0 kg/m2.
Exclusion criteria
Exclusion criteria: Subjects are excluded from the trial if any of the following criteria apply: 1. Known or suspected hypersensitivity to trial product(s) or related products. 2. Previous participation in this trial. Participation is defined as signed informed consent. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). 4. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screeninga.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus regimen. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%. VV-Timepoint: Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting plasma glucose (FPG) From baseline week 0 (V2) to week 26 (V28)Timepoint: From baseline week 0 (V2) to week 26 (V28);Number of clinically significant hypoglycaemic episodes (level 2) (3.0 mmol/L (54 mg/dL), confirmed by BG meter)Timepoint: From baseline week 0 (V2) to week 31 (V30);Number of clinically significant hypoglycaemic episodes (level 2) (3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)Timepoint: From baseline week 0 (V2) to week 31 (V30);Number of severe hypoglycaemic episodes (level 3) From baseline week 0 (V2) to week 31 (V30)Timepoint: From baseline week 0 (V2) to week 31 (V30);Time in target-range 3.9â??10.0 mmol/L (70-180 mg/dL) From week 22 (V24) to week 26 (V28)Timepoint: From week 22 which is V24 to week 26 which is V28 | — |
Countries
Belgium, India, Italy, Japan, Mexico, Netherlands, Romania, Russian Federation, United States of America
Contacts
Public ContactMaya Sharma
Novo Nordisk India Private Ltd.
Outcome results
None listed