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.

Comparative Efficacy And Safety Of Imeglimin Plus Metformin Versus Vildagliptin Plus Metformin In Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Patients: A Randomized, Open-Label Study - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060291

Enrollment

106

Registered

2023-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: imeglimin plus metformin: group A will receive tablet imeglimin 500-2g/day 3 months plus tablet metformin 500-2.5g/day 3 months group B will receive tablet vildagliptin 50-100mg/day 3 m

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Age 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

Design outcomes

Primary

Measure	Time frame
•To evaluate the efficacy & safety of Imeglimin in achieving glycemic control in newly diagnosed Type 2 diabetes mellitus (T2DM) patients compared with standard therapy with vildagliptin.Timepoint: FBG-0 4WeeK 8WeeK 12WeeK PPBS-0 4WeeK 8WeeK 12WeeK HbA1C-0 12 WeeK	—

Secondary

Measure	Time frame
•To evaluate the effect of Imeglimin(a new anti-diabetic medicine) on metabolic profile (body weight, waist circumference, lipid profile), diabetic retinopathy, renal parameters (KFT & spot urine albumin/ creatinine ratio), & hepatic involvement (LFT) in newly diagnosed Type 2 diabetes mellitus (T2DM) patients in comparison with standard therapy with old anti diabetic medicine i.e., vildagliptin.Timepoint: 1. BP AND PULSE RATE 0 4 8 12 WEEKS. 2. Diabetic retinopathy at day 0, 8th & 12th week 4. KFT, spot urine albumin/ creatinine, LFT, weight, waist circumference at 0 & 12th week 5. Adverse drug reactions at any point of occurrence	—

Measure

Time frame

•To evaluate the effect of Imeglimin(a new anti-diabetic medicine) on metabolic profile (body weight, waist circumference, lipid profile), diabetic retinopathy, renal parameters (KFT & spot urine albumin/ creatinine ratio), & hepatic involvement (LFT) in newly diagnosed Type 2 diabetes mellitus (T2DM) patients in comparison with standard therapy with old anti diabetic medicine i.e., vildagliptin.Timepoint: 1. BP AND PULSE RATE 0 4 8 12 WEEKS. 2. Diabetic retinopathy at day 0, 8th & 12th week 4. KFT, spot urine albumin/ creatinine, LFT, weight, waist circumference at 0 & 12th week 5. Adverse drug reactions at any point of occurrence

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Countries

India

Contacts

Public ContactDr Sana Bashir

Government medical College, Jammu

dr_vishaltandon@yahoo.com9419195126

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026