Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 Diabetes patients not controlled by Metformin alone (with HbA1C > 7% ) Age > 20 years and Both male and female gendersÂ
Exclusion criteria
Exclusion criteria: Type 2 Diabetes patients who are already on any DPP4 inhibitors & Metformin combination therapy or on Insulin or any other incretin based therapy or any hypoglycaemic agents Patients with any acute inflammatory/ infective condition with CRP > 10 mg/L and any history of acute infection/ inflammation in past 3 months Patients with chronic inflammatory conditions, autoimmune diseases, Neoplasia Patients with serious macrovascular complications such as acute MI, angina or stroke within six months of enrolment Type 1 Diabetes patients or any other form of diabetes Pregnant or Breastfeeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in hsCRP & plasma insulin levels Changes in lipid profile,body weight, BP, Glycemic profile, Cardiovascular-Renal indicesTimepoint: Changes in hsCRP & plasma insulin levels Changes in lipid profile,body weight, BP, Glycemic profile, Cardiovascular-Renal indices at baseline and end of treatment - 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy,safety,cost,compliance,adherence pattern,treatment satisfaction for TeneligliptinTimepoint: Baseline (0 weeks), End of study (12 weeks) | — |
Countries
India
Contacts
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH