FindTrial
Sign In

A clinical trial to study the effects of two drugs, Metformin Immediate Release and Metformin Extended Release in newly diagnosed type 2 diabetes mellitus patients.

A study to evaluate the efficacy and safety of metformin immediate release versus metformin extended release in drug naive patients with type 2 diabetes mellitus: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033194
Enrollment
70
Registered
2021-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Metformin Extended Release(XR): Metformin XR 1000 mg tablet orally once daily with evening meal Control Intervention1: Metformin immediate release(IR): Metformin IR 500mg tablet orally

Sponsors

Bangalore Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed Type 2 Diabetes Mellitus Patients as per American Diabetes Association guidelines.3 2. Patients of either sex aged �18years to �60 years. 3. Patients willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Newly diagnosed Type 2 diabetes mellitus patients with glycemic markers HbA1C >8.5, FBS >160mg/dl, PPBS > 260mg/dl. 2. Patients suffering with any other co-existing medical illness. 3. Patients not willing to give written informed consent. 4. Women who were pregnant or breastfeeding. 5. Patients with serum creatinine level > 1.2 mg/dl.

Design outcomes

Primary

MeasureTime frame
1. To compare the efficacy of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus. 2. To compare the safety of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus. Timepoint: Baseline and Week 12—

Secondary

MeasureTime frame
. To compare the safety of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus.Timepoint: Week 4—

Countries

India

Contacts

Public ContactDr Syed Salman Farookh

Bangalore Medical College and Research Institute

lkamathbmcri@gmail.com

Outcome results

None listed

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