A study to compare efficacy and safety of Imeglimin versus Vildagliptin in type-2 diabetes mellitus
Phase 3
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/09/057663
- Lead Sponsor
- Dr Noor Husain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Diabetes mellitus with HbA1c between 7.5% to 9%, patients already on Metformin more than 100mg daily along with Glimepiride 1 to 2 mg daily.
Exclusion Criteria
1) Type 1 Diabetes mellitus, cardiovascular disease, renal failure,abnormal liver function test or hepatic disease.
2) more than 2 hypoglycemic drugs, within 12 weeks has received Imeglimin or Vildagliptin
3) Diabetic retinopathy, pancreatitis
4) Pregnant and lactating women, known contraindication, hypersensitivity or allergies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1cTimepoint: Every 3 months till 12 months
- Secondary Outcome Measures
Name Time Method Proportion achieving HbA1c less than 7%, change in Blood glucose fasting and post prandial, Change in BMI.Timepoint: 52 weeks;Safety outcome, symptomatic hypoglycemia or blood glucose less than 50mg/dl, different adverse drug reactions.Timepoint: Any time up to 52 weeks