Clinical evaluation of Diabepal tablet in comparison with Placebo tablet in Type 2 Diabetic Patients
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2014/10/005076
- Lead Sponsor
- Arjun Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 80
1. Subjects suffering from Type 2 Diabetes Mellitus for more than one year,
2. Subject stabilized on mono/ polydrug anti-diabetic therapy for at least last 3 months.
3. Subjects having their fasting blood glucose in the range of 126 -252 mg/dl on screening visit
4. HbA1C in range of 7-11%
5. Subjectâ??s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia
6. Subjects with controlled blood pressure and controlled lipid levels
1.Subjects on insulin therapy
2.Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2
3.Subjects having known hepatic or renal disease
4.Subjects having an active malignancy
5.Subjects with history of significant cardiovascular event < 12 weeks prior to randomization
6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method