Type II Diabetic STUDY
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2016/01/006486
- Lead Sponsor
- SV Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 270
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.
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.
11.Congestive heart failure requiring pharmacological treatment.
12.History of Unstable angina within the past six months.
13.Acute metabolic diabetes complications during the 3 months prior to enrollment in this study.
14.History of acute coronary syndrome within the past 6 months.
15.Subjects on anti-tuberculosis treatment.
16.Subjects on any other chronic ailment treatment such as HIV, hepatitis B, hepatitis C and chronic kidney failure.
17.History of allergy to any of the drugs / investigational products.
18.History of chronic alcoholism.
19.Planned surgical intervention during the expected study duration.
20.History of any surgical interventions during 3 months prior to enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change from baseline in HbA1c at week 12Timepoint: 90
- Secondary Outcome Measures
Name Time Method The change is FBS/ PBS at week 12. <br/ ><br>The change in BMI from baseline to end of week 12. <br/ ><br>The number of participants with episodes of hypoglycemic events in each arm. <br/ ><br>The number of serious adverse events reported in the study.Timepoint: 90