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A Clinical Trial To Compare The Efficacy And Safety Of Imeglimin ( A Novel Anti-Diabetic agent) With Existing Anti-Diabetic Agents In Newly Diagnosed Type 2 Diabetes Patients.

Phase 3
Conditions
Health Condition 1: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2023/11/060291
Lead Sponsor
Government Medical College, Jammu
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Age: =18-60 years (both male and female).

2.Newly diagnosed type 2 diabetes mellitus (T2DM) patients (FBG =126mg/dl, PPBS = 200mg/dl with symptoms like polyuria, polydipsia and polyphagia, 2 hours plasma glucose OGTT = 200mg/dl and HbA1C = 6.5%) diagnosed within 6 months from starting of this study and attending the Endocrinology outpatient department (OPD).

3.HbA1C 6.5-8 %

4.Those who are willing to participate and give their consent shall be included in the study.

Exclusion Criteria

1.Age <18 years and > 60 years

2.Type 1 Diabetes Mellitus patients.

3.T2DM patients having renal dysfunction with eGFR = 45ml/min.

4.T2DM patients with hepatic impairment with child Turcotte Pugh (CTP) class C.

5.Steroid induced T2DM/ Syndromic diabetes.

6.Pregnant/ lactating women with diabetes.

7.Patients not able to tolerate the therapy or presented with adverse drug reaction.

8.Unwilling to participate

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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