Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: CagriSema: Cagrilintide B, semaglutide I,
DV3384 pen-injector. Route of administration-Subcutaneous. Product strength:
A1: Cagrilintide B 1.0 mg/mL
and semaglutide I 0.5 mg/mL
A2: Cagr
Sponsors
Novo Nordisk
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change in HbA1c 2) Relative change in body weightTimepoint: 1) From baseline (week 0) to end of treatment (week 68) 2) From baseline (week 0) to end of treatment (week 68) | — |
Secondary
| Measure | Time frame |
|---|---|
| To confirm superiority of CagriSema 2.4 mg per 2.4 mg versus tirzepatide 15 mg on change in HbA1cTimepoint: From baseline (week 0) to end of treatment (week 68);To compare the effect of CagriSema 2.4 mg per 2.4 mg versus tirzepatide 15 mg on Change in FPGTimepoint: From baseline (week 0) to end of treatment (week 68);To compare the effect of CagriSema 2.4 mg per 2.4 mg versus tirzepatide 15 mg on Achievement of more than or equal to 5 percent weight reductionTimepoint: From baseline (week 0) to end of treatment (week 68);Achievement of HbA1c target values of less than 7.0 percent(less than 53 mmol per mol)Timepoint: At end of treatment (week 68);Achievement of HbA1c target values of less than 6.5 percent (less than 48 mmol per mol)Timepoint: At end of treatment (week 68);Achievement of more than 10 percent weight reductionTimepoint: From baseline (week 0) to end of treatment (week 68);Achievement of more than 15 percent weight reductionTimepoint: From baseline (week 0) to end of treatment (week 68);Achievement of more than 20 percent weight reductionTimepoint: From baseline (week 0) to end of treatment (week 68);Change in systolic blood pressureTimepoint: From baseline (week 0) to end of treatment (week 68);Change in diastolic blood pressureTimepoint: From baseline (week 0) to end of treatment (week 68);Change in waist circumferenceTimepoint: From baseline (week 0) to end of treatment (week 68);Ratio to baseline in lipids Total cholesterol HDL cholesterol LDL cholesterol VLDL cholesterol Triglycerides non-HDL cholesterolTimepoint: From baseline (week 0) to end of treatment (week 68);Change in SF-36v2 score Physical Component Summary score Mental Component Summary scoreTimepoint: From baseline (week 0) to end of treatment (week 68);Change in IWQOL-Lite-CT: Physical Function score Total scoreTimepoint: From baseline (week 0) to end of treatment (week 68);To compare the safety and tolerability of CagriSema 2.4 mg | — |
Countries
Argentina, Australia, Canada, Colombia, India, South Africa, Taiwan, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Pvt. Ltd.
Outcome results
None listed