Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: IcoSema: IcoSema. Solution for injection, Subcutaneous (into the thigh, upper
arm or abdomen), 700 units/mL + 2 mg/mL,Administer IcoSema once weekly, on
the same day each week, at any t
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female and age above or equal to 18 years at the time of signing the informed consent. 2. Diagnosed with T2D greater than or equal to 180 days before screening. 3. HbA1c greater than or equal to 8.0% (greater than or equal to 64.0 mmol/mol) as assessed by central laboratory on the day of screening. 4. 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. 5. Currently treated with 1-3 OADs with stable daily doses greater than or equal to 90 days before screening comprising any of the following anti-diabetic drug(s) at effective or maximum tolerated dose: Metformin, Sulfonylureas, Meglitinides (glinides), DPP-4 inhibitors, Sodium-glucose co-transporter 2 inhibitors, Alpha-glucosidase-inhibitors, Thiazolidinediones, marketed oral combination products only including the products listed above. 6. Body mass index (BMI) less than or equal to 40.0 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. 2. 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). 3. Any episodesa 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. 4. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.b 5. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. 6. Chronic heart failure classified as being in New York Heart Association Class IV at screening. 7. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. 8. 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 aas declared by the participant or in the medical records, bFor Turkey, stricter exclusion criteria applies “Presence or history of pancreatitis (acute or chronic) ? For Italy, an additional exclusion criteria “known severe diabetic autonomic neuropathy as judged by the investigator ? is applicable. Data monitoring committee: No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c %Timepoint: from baseline week 0 (V2) to week 40 (V42). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight KgTimepoint: From baseline week 0 (V2) to week 40 (V42;Time in range 3.9-10.0 mmol/L (70-180 mg/dL) Using study provisioned continuous glucose monitoring (CGM) system, Dexcom G6Timepoint: From week 36 (V38) to week 40 (V42);Time spent 3.0 mmol/L (54 mg/dL) aUsing study provisioned continuous glucose monitoring (CGM) system, Dexcom G6Timepoint: From week 36 (V38) to week 40 (V42);Time spent 10.0 mmol/L (180 mg/dL) Using study provisioned continuous glucose monitoring (CGM) system, Dexcom G6Timepoint: From week 36 (V38) to week 40 (V42);Weekly basal insulin doseTimepoint: From week 38 (V40) to week 40 (V42);Change in fasting plasma glucose (FPG) mmol/LTimepoint: From baseline week 0 (V2) to week 40 (V42);Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction- Score 0-36 bHigher the score the greater the satisfaction with medicationTimepoint: From baseline week 0 (V2) to week 40 (V42);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 45 (V44);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 45 (V44);Number of severe hypoglycaemic episodes (level 3)Timepoint: From baseline week 0 (V2) to week 45 (V44) | — |
Countries
China, Greece, India, Italy, Japan, Poland, South Africa, Turkey, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private Ltd
Outcome results
None listed