Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: GM1V: The subjects diagnosed with type 2 diabetes mellitus and having uncontrolled diabetes, even after dual therapy of metformin 500mg + glimepiride 1 mg for at least three months alon
Sponsors
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female Subjects, 18 years of age or older with known case of Type 2 Diabetes Mellitus. 2. Subjects must have an glycated (or glycosylated) haemoglobin (HbA1c) > 7 % despite dual therapy (Metformin 500 mg + Glimepiride 1/2 mg) 3. Subjects Uncontrolled on and life style modifications interventions 4. Subjects who have HbA1c >9% and are naïve to treatment 5. Willing to complete all study-related procedures 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. Subjects with history of Type I Diabetes Mellitus (DM) or a secondary form of diabetes (Diabetes caused by the pancreatic diseases) 2. Subjects with a medical history of unstable angina, or heart failure (New York Heart Association class III-IV) or any clinically significant electrocardiogram (ECG) abnormalities such as ventricular tachycardia or a medical history of ventricular tachycardia 3. Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty within the last 12 months 4. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation 5. Participation in another trial with an investigational drug within 2 months prior to informed consent. 6. The subject has diastolic blood pressure > 100 millimeters of mercury (mmHg) and/or systolic blood pressure >180 mmHg 7. Subjects having high triglyceride levels > 500 milligram/decilitre (mg /dl) 8. Women who are pregnant or breastfeeding 9. Subjects unable or unwilling to use acceptable birth control methods 10. Hypersensitivity to any of the components of the formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the HbA1C (%) from baseline to end of studyTimepoint: Base line to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight from Baseline to end of the studyTimepoint: Baseline and week 12;Change in the lipid variables from baseline to end of the study (Total cholesterol, Triglycerides, LDL-C, HDL-C)Timepoint: Baseline and week 12;Changes in Fasting Plasma Glucose (FPG) and 2 hour Postprandial Plasma Glucose (PPG) from Baseline to Week 12Timepoint: Baseline, week-2, week-4, week-8 and week-12;Safety and tolerability : The adverse effects of the study drug will be assessed by monitoring adverse events, vital signs, physical examination and clinically significant changes in laboratory parametersTimepoint: Baseline to end of the study | — |
Countries
India
Contacts
Public ContactDr Krishna Kumar M
Micro Labs Limited, Bangalore
Outcome results
None listed