A Study to Understand the Interaction between Ranitidine and Anti-Diabetic drug Metformin in Newly Diagnosed Diabetic Patients
- Conditions
- Health Condition 1: null- Patients newly diagnosed with type II diabetes mellitus and to be started on Metformin.
- Registration Number
- CTRI/2017/10/010139
- Lead Sponsor
- School of Pharmaceutical Sciences Vels University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 17
1. Newly diagnosed with type II diabetes mellitus (as per standard diagnostic criterion).
2. Willing to provide a written informed consent and return for followup after four weeks.
1. Patients whose glomerular filtration rate is less than 60mL/min.
2. Patients with life threatening conditions including malignancies with or without CNS involvement, known cases of coronary artery disease, recent history of STEMI/NSTEMI, ischemic or hemorrhagic stroke, recent history of head trauma or any major physical injury and any other underlying condition which may predispose the subject to risk of serious adverse events.
3. Patients on medication known to alter metformin pharmacokinetics.
4. Patients with severe anemia in whom withdrawal of blood by venipuncture is not recommended.
5. Patients who are mentally unstable with underlying psychiatric illness.
6. Pregnant and lactating women.
7. Patients who are unwilling either to provide a written informed consent or return for follow up after four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alteration in pharmacokinetic profile of metformin by co-administration of ranitidine.Timepoint: Day 1, Day 30
- Secondary Outcome Measures
Name Time Method Adjustment of confounding effect of age and renal function.Timepoint: Day 30
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