A diabetic study to find the safety and efficacy of newer drug Imeglimin.

Phase 4

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2023/06/053822
• Lead Sponsor: Dr Shaki Sam

Brief Summary

1) Duration of data collection will be 3 months.

2) The participants will be selected by the given inclusion and exclusion criteria.

3) Selected study participants will be Randomized using Simple Random Method(Computerised Random Number generation method) into 2 groups ie, Group A  &

Group B.

4)Samples required for baseline investigations for the study will be collected(HbA1c,FBS,PPBS,RFT,LFT,Lipid Profile,Urine microalbiminuria,12 lead ECG).

5)Group A will be treated with Imeglimin+Metformin & the  Group B with Metformin+ Placebo.The Placebo is of similar size & color of the test drug.

6)During 4th & 8th week follow up FBS, PPBS & Urine microalbuminuria will be collected.

7)During 12th week follow up all baseline investigations for the study will be repeated.

8)All the collected data will be compared and analysis will be done.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-26
• Last Update Posted: 2025-02-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 140

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 didn’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 level	3 months

Secondary Outcome Measures

Name	Time	Method
To determine the changes in baseline fasting plasma glucose and pro insulin/insulin ratio	3 months

Trial Locations

Locations (1)

Karpaga Vinayaga Institute of Medical Sciences and Research Centre; 🇮🇳 Kancheepuram, TAMIL NADU, India

Karpaga Vinayaga Institute of Medical Sciences and Research Centre

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Shaki Sam

Principal investigator

6380757173

drshakisam@gmail.com