Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: CagriSema 1.0 mg/ 1.0 mg: It is an IMP, test product. The route of administration is Subcutaneous. Injections should be administered in the thigh, abdomen, or upper arm, at any time of
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all the following criteria apply: 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 greater than or equal to 180 days before screening. 5. Stable daily dose(s) greater 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 - SGLT2 inhibitor 6. HbA1c 7.0-10.5percent (53-91 mmol per mol) (both inclusive) as determined by central laboratory at screening. 7. BMI greater 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: Participants are excluded from the study if any of the following criteria apply: Diabetes- or weight-related: 1. Renal impairment with estimated Glomerular Filtration Rate determined by central laboratory at screening. 2. Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is 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. Planned initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones or systemic 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 year before 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. General safety: 7. Known or suspected hypersensitivity to investigational medicinal product(s) or related products. 8. Previous randomisation in this study. 9. Previous rescreening in this study. 10. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. 11. Participation (i.e., signed informed consent) in any other interventional clinical study within 60 days before screening. 12. History of chronic pancreatitis. 13. Acute pancreatitis within 180 days before screening. 14. Any disorder which in the investigatorâ??s opinion might jeopardise the participantâ??s safety or compliance with the protocol. 15. Planned major change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, as per investigator discretion. 16. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. 17. Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 180 days before screening. 18. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening. 19. Planned coronary, carotid or peripheral artery revascularisation. 20. Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screeni
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 60) 2.From baseline (week 0) to end of treatment(week 60) | — |
Secondary
| Measure | Time frame |
|---|---|
| To confirm superiority of CagriSema 1.0 mg per 1.0 mg versus tirzepatide 5 mg on change in HbA1cTimepoint: From baseline (week 0) to end of treatment (week 60);To compare the safety and tolerability of CagriSema 1.0 mg per 1.0 mg versus tirzepatide 5 mgTimepoint: From baseline (week 0) to end of study (week 66) | — |
Countries
Argentina, Australia, Brazil, Canada, Germany, Greece, Hungary, India, Israel, Poland, Romania, Spain, Taiwan, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private
Outcome results
None listed