Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Tablet Trigotab 1000 milligram: One tablet each to be taken orally in the morning and evening before food for 12 weeks
Control Intervention1: Identical looking placebo tablet: One table
Sponsors
Azista Industries Pvt Ltd A division of Hetero Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender aged between 18 to 65 years 2. Patients with type 2 diabetes mellitus with fasting blood glucose not exceeding 180 mg per dL 3. HbA1c more than 7.5 gram per dl 4. Patients on standard antidiabetic drugs for at least one month 5. Willing to report response to treatment as per protocol during the study period 6. Willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Diabetes other than type 2 DM 2. Pregnant or lactating women 3. Subjects participating in other clinical trials within last 30 days 4. Underlying or diagnosed medical illnesses or deemed unsuitable for this clinical trial according to the judgment of the study clinicians 5. Use of illicit drugs 6. Expecting poor compliance to treatment 7. Clinically significant abnormalities in the screening laboratory values 8. Patients using drugs influencing glucose metabolism steroids hormonal contraceptives menopausal HRT phenytoin colchicine etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in HbA1c between the treatment groupsTimepoint: 0 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting insulin levels and C-peptide levels Timepoint: 0 and 12 weeks;Change in Fasting blood glucose levels at the each of the study visits as compared to baseline Timepoint: 0 and 12 weeks;Change in hemogram and markers for liver and renal function Timepoint: 0 and 12 weeks;Treatment emergent adverse events (TEAE)Timepoint: 0 and 12 weeks | — |
Countries
India
Contacts
Public ContactDebasish Hota
AIIMS, BHUBANESWAR
Outcome results
None listed