Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: NNC0519-0130: Pharmaceutical form : Solution for injection
Route of administration Subcutaneous (s.c.)
Dose: 24mg
Dose frequency: Once weekly
total duration :36 Week
Intervention2: Pl
Sponsors
Novo Nordisk India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female of non-childbearing potential, or male. 2.Age 18-75 years (both inclusive) at the time of signing the informed consent. 3.Diagnosed with type 2 diabetes mellitus more than or equal to 180 days before screening. 4.Stable daily dose(s) more than or equal to 90 days before screening 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 SGLT2 inhibitor. 5.HbA1c of 7.5-10.0 percent (58-86 mmol per mol) (both inclusive) as assessed by central laboratory at screening. 6.BMI more than or equal to 23.0 kg per m2.
Exclusion criteria
Exclusion criteria: 1.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. 2.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. 3.Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1cTimepoint: From baseline (week 0) to 12 weeks on a given maintenance dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weightTimepoint: From baseline (week 0) to end of treatment (week 36);Change in fasting plasma glucose (FPG)Timepoint: From baseline (week 0) to 12 weeks on a given maintenance dose;Continuous glucose monitoring (CGM) Change in time in range (TIR) 3.9–10.0 mmol per L (70–180 mg per dL)Timepoint: From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively;Number of adverse eventsTimepoint: From baseline (week 0) to end of study (week 40) | — |
Countries
Australia, Canada, India, Japan, Republic of Korea, South Africa, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private Limited
Outcome results
None listed