Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: nil: nil
Control Intervention1: nil: nil
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or Female patients 18 to 65 years. Patients uncontrolled on dual therapy (Glimepiride + Metformin) or (Sitagliptin + Metformin) with HbA1c more than 7.5 & less than 8.5 %. Treatment-naïve with HbA1c more than 7.0 & less than 9.0%. Patients with FBG more than 126 mg/dl & PPG more than 200 mg/dl. Patients not taking any other OAD drugs. Patient willing to enroll for the study.
Exclusion criteria
Exclusion criteria: History of Type 1 diabetes. Patients were treated with insulin within 8 weeks of screening. Patients with renal dysfunction (crcl less than 60 ml/min) or proteinuria. History of hypersensitivity. Intolerance to the use of Sitagliptin, Glimepiride or Metformin. Pregnant and lactating women. Patients with Congestive Heart Failure, Unstable angina or ACS within past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c from baseline to 12 ± 1 weeks of treatment. Mean change in FBG and 1 & 2-h PPG levels from baseline to 4 ± 1 weeks and 12 ± 1 weeks followup. Mean change in weight after 12 ± 1 weeks of treatment from baseline. Drug-Dose utilization pattern.Timepoint: From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment adherence and compliance. Safety assessment and tolerability. Physician’s Global Assessment for improvement and user experience.Timepoint: From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup. | — |
Countries
India
Contacts
Public ContactDr Rathish Nair PhD MBA
Torrent Pharmaceuticals Ltd
Outcome results
None listed