CTRI/2016/01/006486
Recruiting
Phase 4
Comparative Evaluation of Efficacy and Safety of Metformin Glimepiride combination (s) and Sitagliptin Metformin Combination Treatment in Patients with Type 2 Diabetes: A open label, randomized, multicentre, Investigator Initiated Study in Indian Population
SV Limited0 sites270 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Sponsor
- SV Limited
- Enrollment
- 270
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects aged between 18 â?? 65 years of either sex.
- •2\.Subjects newly diagnosed with Type 2 Diabetes.
- •3\.Subjects with uncontrolled Type 2 Diabetes currently on metformin monotherapy. Uncontrolled diabetes as:
- •FBS ( \>\= 126mg/dL and \<\= 200 mg/dL) and or 2 h post prandial (\>\= 200 mg/dL)
- •HbA1c levels \>\= 7\.5% and \<\= 10% at screening (Visit 1\).
- •4\.Women of childbearing potential who agree to not to become pregnant and use an appropriate contraceptive method (hormonal, IUD, or diaphragm).
- •5\.Subjects willing to sign the Informed Consent Form and comply with the study visit as per protocol and perform 5\-point home blood glucose monitoring as per protocol.
- •6\.Subjects willing to provide audiovisual recording of the consent process.
- •7\.Agree to follow recommended diet plan and physical activity instructions throughout the study.
Exclusion Criteria
- •1\.Subjects with type 1 diabetes or secondary forms of diabetes.
- •2\.Patients requiring insulin for glycemic control and or History of Insulin usage during 3 months preceding enrollment.
- •3\.A pregnant or lactating women.
- •4\.A female subject intends to become pregnant during the expected study duration.
- •5\.Fasting Blood Sugar ( \< 126mg/dL) and or 2 h post prandial ( \< 200 mg/dL).
- •6\.HbA1c levels \<\= 7\.5% and \>\= 10% at screening.
- •7\.Subjects who are currently on a combination therapy with 2 or more oral anti\-diabetic agents.
- •8\.Subjects with history of diabetic ketoacidosis and vascular complications.
- •9\.Clinically significant renal disease with serum creatinine \> 1\.5 ULN.
- •10\.Clinically significant liver disease with ALT and AST values 2\.5 times ULN.
Outcomes
Primary Outcomes
Not specified
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