Health Condition 1: null- Patients newly diagnosed with type II diabetes mellitus and to be started on Metformin.
Conditions
Interventions
Intervention1: Ranitidine 150mg BD via oral route for two days: Ranitidine will be co-administered with metformin on day one and day 30
Control Intervention1: Metformin 500mg BD via Oral route for one
Sponsors
School of Pharmaceutical Sciences Vels University
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alteration in pharmacokinetic profile of metformin by co-administration of ranitidine.Timepoint: Day 1, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adjustment of confounding effect of age and renal function.Timepoint: Day 30 | — |
Countries
India
Contacts
Public ContactAnisha E
Vels University
Outcome results
None listed