A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switchingfrom Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2Diabetes

Phase 3

Conditions: Health Condition 1: E11- Type 2 diabetes mellitus

Registration Number: CTRI/2024/05/067886

Lead Sponsor: ovo Nordisk India Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Diagnosed with T2D for more than or equal to 180 days prior to the day of screening.

2 HbA1c from 7.0 to 10.0 percent (53.0 to 85.8 mmol per mol), both inclusive, at screening confirmed by central laboratory analysis.

3 Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin,

insulin degludec, insulin detemir, insulin glargine 100 U per mL, or insulin glargine 300 U per mL) more than or equal to 90 days prior to the day of screening with or without any of the following anti diabetic drugs or regimens with stable doses more than or equal to 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), DPP 4 inhibitors, SGLT2 inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti diabetic drugs), oral or injectable GLP 1 RAs, injectable GLP 1 or GIP RA combination products.

4 Body mass index (BMI) less than 40.0 kg per m2.

Exclusion Criteria

1 Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.

2 Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient

ischaemic attack within 180 days prior to the day of screening.

3 Chronic heart failure classified as being in New York Heart Association Class IV at

screening.

4 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).

5 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the effect on glycaemic <br/ ><br>control of once-weekly insulin icodec, <br/ ><br>switched unit-to-unit from a daily basal <br/ ><br>insulin, with or without non-insulin antidiabetic <br/ ><br>drugs, in participants with T2D <br/ ><br>treated with basal insulin. This includes <br/ ><br>comparing the difference in change from <br/ ><br>baseline in HbA1c between insulin icodec <br/ ><br>and insulin glargine U100 after 26 weeks of <br/ ><br>treatment to a non-inferiority margin of <br/ ><br>0.3%-point - Change in HbA1cTimepoint: From baseline week 0 <br/ ><br>(V6) to week 26 (V32)

Secondary Outcome Measures