A research study to see how much CagriSema lowers blood sugar and body weight compared to tirzepatide in people with type 2 diabetes treated with metformin with or without an SGLT2 inhibitor

Phase 3

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

Registration Number: CTRI/2024/03/064047

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male or female.

2. Age 18 years or above at the time of signing the informed consent.

3. Diagnosed with type 2 diabetes more than or equal to 180 days before screening.

4. Stable daily dose(s) more than or equal to 90 days before screening of any of the following antidiabetic drug(s)

or combination regimen(s) at effective or maximum tolerated dose as judged by the

investigator: metformin with or without an SGLT2 inhibitor.

5. HbA1c 7.0-10.5 percent (53-91 mmol per mol) (both inclusive) as determined by central laboratory at

screening.

6. BMI more than or equal to 30 kg per m2 at screening. BMI will be calculated in the eCRF based on height and body

weight at screening.

Exclusion Criteria

1.Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing

potential and not using a highly effective contraceptive method.

2.Renal impairment with estimated Glomerular Filtration Rate more than 30 ml per min per 1.73 m2 as determined by central laboratory at screening.

3.Treatment with any medication for the indication of diabetes or obesity other than stated in

the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes

are allowed.

4. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a

fundus examination performed within 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Change in HbA1c <br/ ><br>2) Relative change in body <br/ ><br>weightTimepoint: 1) From baseline <br/ ><br>(week 0) to end of <br/ ><br>treatment (week <br/ ><br>68) <br/ ><br>2) From baseline <br/ ><br>(week 0) to end of <br/ ><br>treatment (week <br/ ><br>68)

Secondary Outcome Measures