Study to compare effect of Vildagliptin vs. Glimepiride on glucose variation in patients not controlled on metformin alone.

A comparative study to assess the effect of Vildagliptin versus Glimepiride on glucose variability in type 2 diabetic patients uncontrolled on metformin alone. - VARIABLE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/12/004244

Enrollment

324

Registered

2013-12-26

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: null- Tyape II Diabetes Mellitus

Interventions

Intervention1: Vildagliptin: Vildagliptin 50 mg BID, oral as dual therapy with metformin 1000 â?? 1500 mg daily (OD or BID). Total duration of therapy: 16 weeks Control Intervention1: Glimepiride: Gli

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who have given written informed consent to participate in the study. 2. Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive). 3. Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c > 7.5 - 9%). 4. Patients with HbA1C levels within the range > 7.5% - 9%. (If a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily).

Exclusion criteria

Exclusion criteria: 1. Age 75 years ; BMI 22 or 40 kg/m2 2. Patients who are on Insulin therapy at the time of study entry. 3. Type 1 Diabetes Mellitus patients. 4. Patients with severe renal (creatinine clearance 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST 3 x ULN). Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976) 5. Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin.

Design outcomes

Primary

Measure	Time frame
â?¢ To compare the effect of Vildagliptin + Metformin versus Glimepiride + Metformin on glucose variability in T2DM patients.Timepoint: 16 Weeks	—

Secondary

Measure	Time frame
To compare the effect of vildagliptin with glimepiride on glycemic variability in terms of â?¢ Percent HbA1c reduction â?¢Glycemic control assessed through CGMS â?¢Percentage of patients reaching the glycemic target of (i) HbA1c â?¤ 6.5% and (ii) HbA1c â?¤ 7.0%, after 16 weeks treatment â?¢Safety end points.Timepoint: 16 Weeks	—

Countries

India

Contacts

Public ContactApurva Gawai

Novartis Healthcare Pvt. Ltd.

apurva.gawai@novartis.com09820992269

Outcome results

None listed

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