Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Insulin icodec: Dose: Insulin icodec is formulated as a 4200 nmol/mL solution equivalent to 700 U/mL and filled in 3 mL cartridges
Frequency route of administration:
Icodec IMP, test
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Diagnosed with T2D for more than or equal to 180 days prior to the day of screening.2 HbA1c from 7.0 to 10.0 percent (53.0 to 85.8 mmol per mol), both inclusive, at screening confirmed by central laboratory analysis.3 Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin,insulin degludec, insulin detemir, insulin glargine 100 U per mL, or insulin glargine 300 U per mL) more than or equal to 90 days prior to the day of screening with or without any of the following anti diabetic drugs or re-gimens with stable doses more than or equal to 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), DPP 4 inhibitors, SGLT2 inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti diabetic drugs), oral or injectable GLP 1 RAs, injectable GLP 1 or GIP RA combination products.4 Body mass index (BMI) less than 40.0 kg per m2.
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to study intervention(s) or related products. 2. Previous participation in this study. Participation is defined as signed informed consent. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method, as defined in Appendix 4 (Section 10.4). 4. Participation (i.e., signed informed consent) in any interventional clinical study within 90 daysbefore screening. Note: Simultaneous participation in a study with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening in the current study. 5. Any disorder, except for conditions associated with T2D, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol. 6. Any episodesa of diabetic ketoacidosis within 90 days prior to the day of screening. 7. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. 8. Chronic heart failure classified as being in New York Heart Association Class IV at screening. 9. Planned coronary, carotid or peripheral artery revascularisation. 10. Renal impairment with estimated Glomerular Filtration Rate (eGFR) 11. Impaired liver function, defined as Alanine Aminotransferase = 2.5 times or Bilirubin >1.5 times upper normal limit at screening. 12. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8 (Section 8.2). 13. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. 14. Inadequately treated blood pressure defined as systolic =180 mmHg or diastolic =110 mmHg at screening. 15. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days prior to the day of screening. 16. 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). 17. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening (V1) and until the start of runin (V2). Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 18. 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 screening. 19. Anticipated change in lifestyle affecting glucose control (e.g., eating, exercise or sleeping pattern) during the study. 20. Use of any medication with unknown or unspecified content within 90 days prior to the day of Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the effect on glycaemic control of once-weekly insulin icodec, switched unit-to-unit from a daily basal insulin, with or without non-insulin antidiabetic drugs, in participants with T2D treated with basal insulin. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin glargine U100 after 26 weeks of treatment to a non-inferiority margin of 0.3%-point - Change in HbA1cTimepoint: From baseline week 0 (V6) to week 26 (V32) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare parameters of glycaemic control, patient reported outcomes and safety of once weekly insulin icodec, switched unit to unit from a daily basal insulin, compared to once daily insulin glargine U100, both treatment arms with or without non insulin anti diabetic drugs, in participants with T2D treated with basal insulin. Secondary efficacy endpoints 1. Change in time in range 3.9 to 10.0 mmol per L (70 to 180 mg per dL) 2. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction Timepoint: 1. From baseline week minus 4 to 0 (V2 to V6) to week 22 to 26 (V28 to V32) 2. From baseline week 0 (V6) to week 26 (V32) ;Secondary safety endpoints 1. Number of severe hypoglycaemic episodes (level 3) 2. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol per L (54 mg per dL), confirmed by BG meter) 3. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol per L (54 mg per dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 4. Time spent less than 3.0 mmol per L (54 mg per dL) 5. Change in time spent more than 10.0 mmol per L (180 mg per dL) 6. Mean weekly insulin dose 7. Change in body weight Timepoint: 1. From baseline week 0 (V6) to week 31 (V34) 2. From baseline week 0 (V6) to week 31 (V34) 3. From baseline week 0 (V6) to week 31 (V34) 4. During week 22 to 26 (V28 to V32) 5. From baseline week minus 4 to 0 (V2 to V6) to week 22 to 26 (V28 to V32) 6. From week 24 (V30) to week 26 (V32) 7. From baseline week 0 (V6) to week 26 (V32) ;Exploratory endpoints Change in TRIM D (Treatment Related Impact Measure for Diabetes) totalTimepoint: From baseline week 0 (V6) to week 26 (V32) | — |
Countries
Bulgaria, Germany, India, Japan, Poland, South Africa, Spain, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private Ltd
Outcome results
None listed