Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: IcoSema: once weekly icosema subcutaneous Injection with Insulin Aspart with or without OADs
Control Intervention1: Insulin Glargine: once daily insulin glargine subcutaneous injection
Sponsors
Novo Nordisk
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 above or equal to 18 years at the time of signing informed consent. 4. Diagnosed with type 2 diabetes mellitus = 180 days before screening. 5. HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening. 6. Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day = 90 days before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti-diabetic drugs with stable doses = 90 days before screening: ? Metformin ? Sulfonylureasa ? Meglitinides (glinides)a ? DPP4 inhibitorsa ? Sodium-glucose co-transporter 2 inhibitors ? Alpha-glucosidase-inhibitors ? Thiazolidinediones ? Marketed oral combination products only including the products listed above. 7. Body mass index (BMI) = 40.0 kg/m2 . 8. Not currently using real time continuous or flash glucose monitoring.
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to randomised treatment 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 a highly effective contraceptive method, as defined in Appendix 4. 4. Participation (i.e., signed informed consent) in any interventional, clinical study within 90 days before 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 and if simultaneous participation is allowed by local authorities. 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. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids). 7. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. 8. Any episodesa of diabetic ketoacidosis within 90 days before screening. 9. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. 10. Presence or history of pancreatitis (acute or chronic) within 180 days before screening. 11. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. 12. Chronic heart failure classified as being in New York Heart Association Class IV at screening. 13. Planned coronary, carotid or peripheral artery revascularisation. 14. Renal impairment measured as estimated glomerular filtration rate value of 15. Impaired liver function, defined as alanine aminotransferase = 2.5 times or bilirubin > 1.5 times upper normal limit at screening. 16. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8. 28 . 17. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. 18. Inadequately treated blood pressure defined as systolic = 180 mmHg or diastolic = 110 mmHg at screening. 19. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 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, see 8.2.4. 20. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in situ prostate cancer) within 5 years before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c - % pointTimepoint: From baseline week 0 (V2) to week 52 (V54) | — |
Secondary
| Measure | Time frame |
|---|---|
| "Change in body weight - in KG "Timepoint: From baseline week 0 (V2) to week 52 (V54);Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfactionTimepoint: From baseline week 0 (V2) to week 52 (V54);Change in fasting plasma glucose (FPG) - in mmol/LTimepoint: From baseline week 0 (V2) to week 52 (V54);Number of clinically significant hypoglycaemic episodes (level 2) (3.0 mmol/L (54 mg/dL), confirmed by BG meter)Timepoint: From baseline week 0 (V2) to week 57 (V56);Number of clinically significant hypoglycaemic episodes (level 2) (3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)Timepoint: From baseline week 0 (V2) to week 57 (V56);Number of severe hypoglycaemic episodes (level 3)Timepoint: From baseline week 0 (V2) to week 57 (V56);Time in range 3.9-10.0 mmol/L (70-180 mg/dL)Timepoint: From week 48 (V50) to week 52 (V54);Time spent 10.0 mmol/L (180 mg/dL)Timepoint: From week 48 (V50) to week 52 (V54);Time spent 3.0 mmol/L (54 mg/dL)Timepoint: From week 48 (V50) to week 52 (V54);Weekly insulin dose (total)Timepoint: From week 50 (V52) to week 52 (V54) | — |
Countries
Czech Republic, France, Germany, Hungary, India, Italy, Japan, Malaysia, Poland, Slovenia, South Africa, Thailand, Turkey, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private Limited
Outcome results
None listed