A diabetic study to find the safety and efficacy of newer drug Imeglimin.
Phase 4
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/06/053822
- Lead Sponsor
- Dr Shaki Sam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Male & Female population
2)HbA1c >6.5 and <10
3)Patients willing to participate and given written informed consent
Exclusion Criteria
1)Those who are on insulin therapy or any injectable glucose lowering drugs in the past 30 days.
2)Pregnant and lactating mother
3)Patients with impaired hepatic or renal function
4)Patients with hypertension,congestive cardiac failure,ischemic heart disease.
5)Clinically significant micro vascular and macro vascular complications
6)Patients who didnâ??t give written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the primary efficacy outcome change of HbA1c levelTimepoint: 3 months
- Secondary Outcome Measures
Name Time Method To determine the changes in baseline fasting plasma glucose and pro insulin/insulin ratioTimepoint: 3 months