A study to evaluate the therapeutic effect of Imeglimin by comparing with existing therapy for Type 2 Diabetes Mellitus
Phase 4
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/11/060206
- Lead Sponsor
- Dr Raj Kamal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Type 2 Diabetes Mellitus patients not controlled on Metformin monotherapy
2. Glycemic control with Hba1c range of > 7.5 and <8 %
3. FBS >126 and <160
4. Type 2 Diabetes Mellitus patients of both genders
5. Type 2 Diabetes Mellitus patients of BMI <22.9 kg/m2
6. Type 2 Diabetes Mellitus patients with written informed consent
Exclusion Criteria
1. Type 1 Diabetes Mellitus
2. Gestational Diabetes Mellitus
3. Liver failure and Renal failure
4. Patients with MIcro and Macro vascular complications
5. Patients with Inflammatory Bowel disease
6. Anaemic patients
7. Patients not willing to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of Tablet Imeglimin in Type 2 Diabetes Mellitus Patients not controlled on Metformin monotherapy with HbA1c reduction of 0.5 to 1.0 % and FBS level less than 126 mg/dlTimepoint: HbA1c reduction of 0.5 to 1.0 % at the end of 3 months and FBS level less than 126 mg/dl at the end of 3 months
- Secondary Outcome Measures
Name Time Method Change in BMITimepoint: 3 months