None listed
Conditions
Interventions
Intervention1: FDC of Glimepiride 1 or 2mg + Metformin 500 mg SR + Pioglitazone 15 mg: Once daily or Twice daily for 180 days. Dose titration applicable as per HbA1c criteria and Investigators Discret
Sponsors
Abbott Healthcare Private Limited, Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1.>18 years of age, upper limit at the discretion of Investigator. 2.Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix B) at least 6 months prior to screening. 3.Patients with type 2 diabetes mellitus who had previously received at least 3 months of continuous treatment with oral therapy of Metformin or Glimepiride alone and is inadequately controlled [HbA1c>8% and HbA1c < 11 %] during screening visit. 4.Patient with BMI between 20 ? 35 Kg/m2. 5.Patients with stable dietary and exercise pattern since three months and willing to follow the same for the entire trial duration. 6.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed
Exclusion criteria
Exclusion criteria: 1.Patients already on insulin therapy in addition to Glimepiride or Metformin therapy. 2.H/O earlier use of dual or triple OAD?s therapy. 3.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months. 4.Cardiac status New York Heart Association (NYHA) III-IV. 5.Uncontrolled Blood pressure [> 140 Systolic and > 90 Diastolic]. 6.Impaired renal function as shown by, but not limited to, serum creatinine &#8805; 1.5 mg/dL for males, or &#8805; 1.4 mg/dL for females. 7.Clinically significant peripheral edema. 8.Acute infection. 9.Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis. 10.Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range. 11.Diabetics on steroids. 12.History of hypoglycemia unawareness. 13.Pregnancy or lactating women. 14.Known hypersensitivity to any Oral hypoglycemic agent. 15.Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ. 16.Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years. 17.Diagnosis of dementia. 18.Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. 19.Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study. 20.Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Decrease in HbA1C from baseline to Day 180. 2. Safety assesments like lab parameter changes from baseline to Day 180.Timepoint: Screening, Baseline, Day 30, Day 90 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients acheiving an HbA1c by > 1%. 2. No. of patients acheiving HbA1c by < 7%. 3. Changes from basline to Day 180 of FPG and PPG. 4. Changes in C-Peptide levels from baseline to Day 180. 5. Changes in lipid parameters from baseline to Day 180. 6. No. of patients with hypoglycemic events. 7. Global assessment for efficacy and tolerability by patient and investigator at Day 180.Timepoint: Screening, Baseline, Day 30, Day 90 and Day 180 | — |
Countries
India
Contacts
Public ContactManoj.M.Prabhu
Chief Manager
Outcome results
None listed