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Safety of Metformin in patients with Diabetes and Early renal failure

TO EVALUATE THE SAFETY OF METFORMIN IN DIABETIC PATIENTS WITH CHRONIC KIDNEY DISEASE STAGE 3 a and b

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/12/004194
Enrollment
50
Registered
2013-12-06
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 with chronic kidney disease stage 3a and 3b

Interventions

Intervention1: Metformin: Patients with CKD stage 3a i.e eGFR 59 â?? 45 ml/min/1.73m2 will receive oral Metformin at a maximum dose of 1 gm twice daily, while those with stage 3b i.e eGFR 44 - 30 ml/m

Sponsors

Dr Manish Rathi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Type 2 diabetes mellitus and CKD stage 3a and 3b whose blood sugar is not controlled with oral hypoglycemic agents other than metformin with or without insulin.

Exclusion criteria

Exclusion criteria: 1) Patients with CKD stage 4 & 5 2) Acute kidney injury 3) Congestive cardiac failure 4) Liver failure 5) Alcohol abuse 6) Hypoxemia 7) Refusal to give consent

Design outcomes

Primary

MeasureTime frame
Serum lactate and Liver function testTimepoint: At baseline, then at 2 weeks and then at 4, 8 & 12 weeks

Secondary

MeasureTime frame
1. Serum creatinine 2. HbA1cTimepoint: 1. At baseline and then at 4, 8, 12 weeks 2. At baseline and then at 12 weeks

Countries

India

Contacts

Public ContactDr Jegan S

Post Graduate Institute of Medical Education and Research

drmanishrathi@gmail.com

Outcome results

None listed

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