A comparative study on efficacy , safety and reduction of diabetic complications, with regimens of metformin, glimeperide, &vildagliptin vs metformin, Glimeperide, & dapagliflozin in type â?? 2 diabetic patients.

A open label, randomized, comparative study on efficacy , safety and reduction of diabetic complications, with regimens of metformin, glimeperide, &vildagliptinvs metformin, Glimeperide, &dapagliflozin in type â?? 2 diabetic patients.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/04/008424

Enrollment

300

Registered

2017-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 Health Condition 2: null- Type 2 Diabetic

Interventions

Intervention1: Dapagliflozin 10mg OD for a period of 2 years: Potent Highly Selective and Orally active inhibitor of the human sodium-glucose co transporter 2 (SGLT2) Control Intervention1: vildaglipt

Eligibility

Inclusion criteria

Inclusion criteria: Males and Females of age between 30-60 years Type â?? 2 diabetics already on treatment but with uncontrolled blood sugars. Type â?? 2 diabetics with hypertension. Type â?? 2 diabetics with obesity.

Exclusion criteria

Exclusion criteria: Males and Females of age above 60 years . Newly diagnosed cases of Type â?? 2. Type â?? 2 diabetics with other endocrinological disorders like hypo or hyperthyroidism, cushingâ??s syndrome and acromegaly, Type â?? 2 diabetics with pancreatic disorders like pancreatitis. , Type â?? 2 Diabetics with acute complications. Type â?? 2 Diabetics on drugs like thiazide diuretics, corticosteroids, oral contraceptive pills, protease inhibitors. Other specific types of diabetes like MODY. Type â?? 2 Diabetics with severe renal failure, heart failure, and hepatic failure. Pregnant & lactating women.

Design outcomes

Primary

Measure	Time frame
Glycemic reduction (HbA1c) by glucose lowering effect of dapagliflozen 10 mg OD vsvildagliptin 50 mg OD when added to metformin and glimepride groupTimepoint: 2 years	—

Secondary

Measure	Time frame
reduction of macro and micro vascular complicationsTimepoint: 3 years	—

Countries

India

Contacts

Public ContactDr Kurli Sankar

Siddhartha Medical College

kurli.sankar@yahoo.com9440673953

Outcome results

None listed

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