A clinical trial to study the effect of Fixed Dose Combination of Repaglinide / Metformin IR Tablet in the treatment of patients with Type 2 Diabetes Mellitus

A Randomized, Double Blind, Comparative, Prospective, Multicentre, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Repaglinide / Metformin IR Tablet Compared with Metformin IR Tablet Monotherapy or Repaglinide Tablet Monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003247

Enrollment

237

Registered

2012-12-20

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- Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone

Interventions

Intervention1: FDC of Repaglinide 1 mg/2 mg + Metformin 500 mg Tablet: administered twice daily for 16 weeks Control Intervention1: Metformin 500 mg / 1000 mg Tablets: administered twice daily for 16

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 and 2. Patients with Type 2 Diabetes Mellitus who have been treated with Metformin monotherapy for at least 3 months and not adequately controlled. 3. Patients of Type 2 Diabetes Mellitus with Glycosylated Haemoglobin (HbA1c) levels of > 7% to

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy. 3. Patients with known hypersensitivity to any of the components of the formulation 4. Known cases of Diabetic Nephropathy, Diabetic Ketoacidosis, Hyperglycemia hyperosmolar state, Retinopathy, Neuropathy or other diabetic complications of sufficient severity to require treatment 5. Clinically significant cardiovascular disease and/or Electrocardiograph abnormality. 6. Patients who have a recent history or who are currently known to abuse alcohol or drugs. 7. Patients with clinically significant Renal, Hepatic, or Cerebrovascular Disease, Malignancy, Chronic Uncontrolled Systemic Diseases like Asthma, Hypertension, Collagen Disorders, etc. or any other serious medical illness. 8. Patients receiving treatment with systemic corticosteroids. 9. Patients who have participated in any clinical trial in the past 1 month. 10. Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.

Design outcomes

Primary

Measure	Time frame
Mean Change in Glycosylated Haemoglobin (HbA1c) levelsTimepoint: 16 weeks	—

Secondary

Measure	Time frame
1. Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)Timepoint: 16 weeks;2. Global Assessment of Efficacy by the PhysiciansTimepoint: 16 weeks;3. Global Assessment of Tolerability by the PatientsTimepoint: 16 weeks	—

Countries

India

Contacts

Public ContactDr Shailendra Sachan

Glenmark Pharmaceuticals Ltd

piyusha@glenmarkpharma.com912240189999

Outcome results

None listed

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