TO EVALUATE THE EFFICACY AND SAFETY OF TENELIGLIPTIN VERSUS VILDAGLIPTIN AS AN ADD-ON TO METFORMIN IN DIABETES
Phase 4
Not yet recruiting
- Conditions
- 3.Patients with Type 2 DM according to American Diabetes Association (ADA) criteria (FBS 126 mg/dl, PPBS 200 mg/dl.) HbA1c levels between 7% and 9% on monotherapy with Metformin 2g/day for 6 months
- Registration Number
- CTRI/2018/06/014353
- Lead Sponsor
- Praveen A N
- Brief Summary
**Objectives of study:**
1. The primary endpoint of the study is to compare the percentage change in mean HbA1c levels from the baseline and the end of 12 weeks between Teneligliptin vs Vildagliptin as an add-on to Metformin in type 2 DM.
2. The secondary endpoint is to compare the percentage change in mean FBS and PPBS values from the baseline and at the end the 4th, 8th and of 12th weeks of Teneligliptin vs Vildagliptin as an add-on to Metformin in the treatment of type 2 DM.
3. Compare the safety parameters of Teneligliptin vs Vildagliptin in Type 2 DM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
- 1.Patients willing to give written informed consent.(Annexure 1) 2.Patients of either sex aged 18 -80 years 3.Patients with Type 2 DM according to American Diabetes Association (ADA) criteria (FBS >126 mg/dl, PPBS >200 mg/dl.) 4.Type 2 DM who do not achieve glycemic target with metformin alone (upto 2g/day) for 6 months.
- 5.Patients with HbA1c levels between 7% and 9% on monotherapy with Metformin 1.5 -2g/day for 6 months prior to visit.
Exclusion Criteria
- Exclusion criteria : 1.Patients who suffered an attack of acute coronary syndrome, transient ischemic attack or stroke in the past three months.
- 2.Patients with hepatic disease (serum level of ALT, AST, Alkaline phosphatase >3times the upper limit of normal) 3.Patients with severe ketosis, coma or reduced level of consciousness within the past 6 months due to diabetes.
- 4.Severe infection, pre or post operative, severe trauma.
- 5.History of a chronic intestinal disease associated with absorption and digestive problems.
- 6.Moderate or severe renal dysfunction (creatinine clearance <50ml/min, serum creatine level>1.5mg/dl in men and 1.3mg/dl in females.
- 7.Subjects with history of type 1 DM or secondary form of diabetes due to pancreatic diseases, pancreatic tumors pheochromocytoma, cushings syndrome, haemochromatosis drugs ,insulin receptors etc.
- 8.Medical history of pancreatitis with history of alcohol and drug abuse.
- 9.Pregnant and lactating mothers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is to compare the percentage change in mean HbA1c levels from the baseline and the end of 12 weeks between Teneligliptin vs Vildagliptin as an add-on to Metformin in type 2 DM. From the baseline and the end of 12 weeks
- Secondary Outcome Measures
Name Time Method To compare the percentage change in mean FBS and PPBS values from the baseline and at the end the 4th, 8th and of 12th weeks of Teneligliptin vs Vildagliptin as an add-on to Metformin in the treatment of type 2 DM. from the baseline to 4th, 8th and of 12th weeks
Trial Locations
- Locations (1)
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
🇮🇳Bangalore, KARNATAKA, India
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE🇮🇳Bangalore, KARNATAKA, IndiaPRAVEEN A NPrincipal investigator8880067200praveengowdadr@yahoo.com