Comparison of Effectiveness and Safety of Imeglimin and Metformin monotherapy in type 2 Diabetes: A Study

Phase 4

Recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2023/08/056584

Lead Sponsor: Other Self

Brief Summary: Diabetes mellitus (DM) is a syndrome characterized by chronic hyperglycemia and

disturbances of carbohydrate, fat, and protein metabolism due to deficiency of insulin (type

1) or insensitivity of the target tissues to insulin (type 2). Oral therapy for type 2 diabetes,

when used appropriately, can safely assist patients to achieve glycemic target in the short

term to medium term. In the current standard of care treatment for newly diagnosed type 2

diabetes mellitus patient, Metformin still finds a place as the first line drug. Although lifestyle

modification remains the mainstay for all patients of type 2 diabetes.

The therapeutic armamentarium for diabetes is growing day-by-day. In this rapidly growing

list of pharmacotherapy for type 2 diabetes is a very new group of oral antidiabetic

tetrahydrotriazineâ€containing drug Imeglimin.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 34

Inclusion Criteria

Newly Diagnosed cases with Type 2 Diabetes Mellitus HbA1c>7.5% and <9%.

Exclusion Criteria

Female patient who are pregnant and lactating Patients on any other glucose lowering agent Establised Cardiovascular disease, Compromised renal Function(eGFR<60) AND Liver function (enzymes>3 ULN) and psychiatric illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of HBA1c at week 16th with respect to week 0	Change of HBA1c at week 16th with respect to week 0

Secondary Outcome Measures

Name	Time	Method
Change in FPG & PPPG	Adverse reaction

Trial Locations

Locations (1): NRS Medical College and Hospital
🇮🇳
Kolkata, WEST BENGAL, India
NRS Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Dr Arjun Baidya
Principal investigator
6351239897
arjun.baidya@gmail.com