A research study to see how well CagriSema compared to semaglutide,cagrilintide and placebo lowers blood sugar and body weight in people with type 2 diabetes treatedwith metformin with or without an SGLT2 inhibitor.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/01/061256
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male or female.
3. Age 18 years or above at the time of signing the informed consent.
4. Diagnosed with type 2 diabetes mellitus = 180 days before screening.
5. Stable daily dose(s) = 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.
6. HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at
screening.
7. BMI = 25 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body
weight at screening.
1. Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 as
determined by central laboratory at screening.
2. 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.
3. 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.
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. Previous or planned (during the study period) obesity treatment with surgery or a weight loss
device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if
performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 yearbefore screening, (3) intragastric balloon, if the balloon has been removed > 1 year before
screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before
screening.
6. A self-reported change in body weight > 5% within 90 days before screening irrespective of
medical records.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To confirm superiority of CagriSema versus <br/ ><br>semaglutide (2.4 mg/2.4 mg versus 2.4 mg <br/ ><br>and 1.0 mg/1.0 mg versus 1.0 mg, <br/ ><br>respectively) on change in HbA1c and/or <br/ ><br>change in body weight in participants with <br/ ><br>T2D in inadequate glycaemic control on <br/ ><br>stable dose of metformin +/-SGLT2iTimepoint: 1)Change in HbA1c- From baseline (week 0) to end of treatment (week 68)- %-points <br/ ><br>2)Relative change in body weight-From baseline (week 0) to end of treatment (week 68)-%
- Secondary Outcome Measures
Name Time Method