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Voglibose v/s Glimepiride Efficacy and Safety in Combination with Metformin in Type-2 Diabetes Mellitus patients

Efficacy and Safety of Voglibose v/s Glimepiride in Combination with Metformin in Type-2 Diabetes: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033005
Enrollment
70
Registered
2021-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: METFORMIN, VOGLIBOSE: 500/0.2 Control Intervention1: METFORMIN, GLIMEPIRIDE: 500/1

Sponsors

AIIMS JODHPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. NEWLY DIAGNOSED T2-DM WITH HbA1c between 7-11% or, 2. T2-DM PATIENT UNCONTROLLED ON METFORMIN 500MG BD (RBS >200 ON ATLEAST 3 OCASSIONS OR HbA1c between 7-11%).

Exclusion criteria

Exclusion criteria: 1. Type-1 DM PATIENTS 2. PREGNANCY & LACTATING WOMEN 3. PATIENTS WITH HEART FAILURE (NYHA CLASS 2-4) 4. PATIENTS WITH HISTORY OF CHRONIC KIDNEY DISEASE (SERUM CREATININE > 1.5mg/dl) 5. PATINETS WITH HISTORY OF LIVER FAILURE 6. PATIENTS WITH HISTORY OF AUTOIMMUNE DISORDERS 7. PATIENTS WITH HISTORY OF COPD.

Design outcomes

Primary

MeasureTime frame
1. Difference of HbA1c reduction in between voglibose and glimepiride group after 3 months 2. Difference in decrease in FBS and PPBS between voglibose and glimepiride group after 3 monthsTimepoint: Baseline and after 1 and 2 and 3 months of treatment—

Secondary

MeasureTime frame
1. Adverse events in both the groups. 2. Difference in lipid parameters (Triglycerides, Total Cholesterol, LDL, VLDL, and HDL) in both the groups after 3 months. 3. Difference in quality-of-life indicators between voglibose and glimepiride group after 3 months. 4. Difference in HOMA â?? IR, HOMA â?? β% and HOMA-S% of voglibose and glimepiride group after 3 months 5. Difference in need and use of rescue medicines in both the groups during 3month study period.Timepoint: Baseline and after 1 and 2 and 3 months of treatment—

Countries

India

Contacts

Public ContactJAYKARAN CHARAN

AIIMS JODHPUR

dr.jaykaran78@gmail.com9825219196

Outcome results

None listed

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