Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: CagriSema (0.25/0.5/1.0/1.7/2.4mg): Injections should be administered Subcutaneously (SC) in the thigh, abdomen, or upper arm, at any time of day
irrespective of meals. Rotation of the
Sponsors
Novo Nordisk India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Renal impairment with estimated Glomerular Filtration Rate (eGFR) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To confirm superiority of CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg on change in HbA1c in participants with T2D in inadequate glycaemic control on stable dose of metformin +/-SGLT2iTimepoint: Change in HbA1c From baseline (week 0) to end of treatment (week 68) %-points | — |
Secondary
| Measure | Time frame |
|---|---|
| To confirm superiority of CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg on change in HbA1c and/or change in body weightTimepoint: From baseline (week 0) to end of treatment (week 68);To confirm superiority of CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg on change in HbA1c and/or change in body weightTimepoint: From baseline (week 0) to end of treatment (week 68);To confirm superiority of cagrilintide 2.4 mg versus placebo on change in 1) HbA1c 2) Body weightTimepoint: From baseline (week 0) to end of treatment (week 68);To confirm superiority of CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg) on: 1) Achievement of = 10% weight reduction 2) Achievement of = 15% weight reduction 3) Achievement of = 20% weight reductionTimepoint: From baseline (week 0) to end of treatment (week 68);To confirm superiority of CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg, respectively) on time in tight range (TITR)Timepoint: From baseline (week -3 to end of treatment (week 68);To confirm superiority of CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg, respectively) on: 1) Systolic blood pressure 2) Triglycerides 3) Non-HDL cholesterolTimepoint: From baseline (week -3 to end of treatment (week 68);To confirm superiority of CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg, respectively) on time in range (TIR)Timepoint: From baseline (week -3) to end of treatment (week 68);To confirm superiority of CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg, respectively) on hsCRPTimepoint: From baseline (week 0) to end of treatment (week 68) | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Romania, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private Ltd
Outcome results
None listed