A Clinical Study to evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an adjuvant to Oral Hypoglycemic agents (OHAs) in Type 2 Diabetic Patients.
- Conditions
- Health Condition 1: null- Type II Diabetes mellitus
- Registration Number
- CTRI/2009/091/000605
- Lead Sponsor
- Tulip Lab Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1. Subjects suffering from type 2 diabetes mellitus for more than one year, and stabilized on mono / polydrug oral anti-diabetic therapy (Sulfonylurea alone or combination of sulfonylurea and Biaguanides) for at least last 3 months.
2. Subjects having HbA1C value between 7-10% (both inclusive) at screening.
3. Subjects having Fasting Plasma Glucose 126-252 mg/dL (both inclusive) at screening.
4. Subjects of male gender or a nonpregnant, nonlactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
5. Subjects having a body mass index (BMI) of 20 ? 35 kg/m2.
6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
1. Subjects on insulin therapy or on oral hypoglycemic agents other than Sulfonylurea and Biaguanides.
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 giving 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.
7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
9. Use of any other investigational drug within 1 month prior to randomization
10. Known hypersensitivity to ingredients used in study drug
11. Pregnant and Lactating females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of TLPL/AY/04/2008 in comparison with matching placebo as add-on therapy to OHA in patients suffering from type 2 Diabetes mellitus by assessing, <br/ ><br> <br/ ><br>1.Changes in Fasting and Postprandial Plasma Glucose levels <br/ ><br>2.Changes in HbA1C% Value <br/ ><br>Timepoint: Day 0, Day 30, Day 60 and Day 90
- Secondary Outcome Measures
Name Time Method 1.Changes in fasting Serum insulin level <br/ ><br>2.Reduction in dose of OHAs <br/ ><br>3.Improvement in clinical symptoms of Type 2 DM <br/ ><br>4. Global assessment for overall improvement by the subject <br/ ><br>5. Global assessment for overall improvement by the investigator <br/ ><br>6. Tolerability of study drugs assessment by study subject and investigator <br/ ><br>7. Laboratory parameters like Liver function tests (LFT), renal function tests (RFT), Lipid Profile, Complete blood count (CBC), ESR, Hb% and Urine Examination <br/ ><br>Timepoint: Day 0, Day 30, Day 60, Day 90