Efficacy and safety of Gemigliptin as add-on therapy to insulin with or without metformin, in patients with type 2 diabetes mellitus
Phase 3
Completed
- Conditions
- Type 2 Diabetes Mellitus PatientsT2DM
- Registration Number
- TCTR20210225005
- Lead Sponsor
- G Chem Life Sciences Ltd.
- Brief Summary
Gemigliptin added to insulin alone or to insulin in combination with metformin resulted in superior glycaemic control compared to that in the placebo group and was well tolerated for 24 weeks in patients with type 2 diabetes mellitus, without causing weight gain or increasing the incidence of hypoglycaemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 290
Inclusion Criteria
Patients with type 2 diabetes mellitus of 19 years and above of age at the time of Visit 1 (Screening) and other details in https://clinicaltrials.gov/ct2/show/NCT02831361
Exclusion Criteria
Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes and other details as in https://clinicaltrials.gov/ct2/show/NCT02831361
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes from baseline HbA1c at week 25 baseline (Visit 2) and week 25 (visit 6) HbA1c
- Secondary Outcome Measures
Name Time Method