CTRI/2022/05/042922
Not yet recruiting
Phase 4
A Phase IV, Prospective, Open Label, Multi-Center, Parallel, Three Arm, Comparative Clinical Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Metformin ER, Glimepiride and Voglibose tablets in Adult Patients with Type 2 Diabetes Mellitus
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hetero Labs Limited
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adult male or female patients aged of 18\-65 years and willing to give written, signed, and dated informed consent to participate in the study.
- •2\.Patients who are on metformin \>\=1500mg/day and \<2550mg/day at the time of screening.
- •3\.Fasting plasma glucose \>\=126 mg/dL (7\.0 mmol/L) and HbA1C of 8%â??11% at screening and end of run\-in period.
- •4\.Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
- •5\.Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range of the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion Criteria
- •1\.Patient with Type 1 diabetes mellitus or secondary diabetes.
- •2\.Patients with known hypersensitivity to any of the components of the study drugs.
- •3\.Patients with fasting plasma glucose \>\=250 mg/dL or \>\=13\.9mmol/L or a history of severe hypoglycemia (blood sugar \<\=50 mg/dL or \<\=2\.8mmol/L).
- •4\.Patients received insulin within 8 weeks prior to screening or Patients requiring insulin therapy or already on insulin therapy.
- •5\.Patients received treatment with a PPARγ agent (e.g., pioglitazone or rosiglitazone) or incretin mimetics (e.g., exenatide) within 12 weeks.
- •6\.Patients receiving treatment with systemic corticosteroids.
- •7\.Patients with a body mass index (BMI) \< 20 kg/m2 or \> 43 kg/m2\.
- •8\.Patients with renal disease or renal dysfunction (creatinine clearance i.e. eGFR \<30 ml/min/1\.73 m2\).
- •9\.Patients planned for intravascular contrast studies with iodinated materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials) during the study period.
- •10\.Patients with history of acute pancreatitis, including fatal and non\-fatal hemorrhagic or necrotizing pancreatitis.
Outcomes
Primary Outcomes
Not specified
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