A study to understand the combined effect of sitagliptin and teneligliptin with metformin in comparison to metformin alone treatment on blood glucose cotrol in patients with type 2 diabetes mellitus.
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2018/03/012413
- Lead Sponsor
- Department of Pharmacology and Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients with 18-70 years of age.
2. Newly diagnosed patients with Type-2 Diabetes Mellitus.
a. Patients with an HBA1c value above or equal to 6.5 percent. OR
b. Patients with fasting glucose above or equal to 126 mg/dl.OR
c. Patients with 2-hour glucose, following ingestion of 75 g glucose load, above or equal to 200 mg. OR
d. Symptomatic patients with random plasma glucose above or equal to 200 mg.
1. Patients with Type - 1 Diabetes Mellitus
2. Patients with a history of severe diabetic complications: Ketoacidosis, Retinopathy, Nephropathy, Neuropathy.
3. Hypersensitivity to any of the used drugs.
4. Pregnant and lactating females
5. Liver and kidney dysfunction or severe anemia
6. Patients with serious cardiovascular disease (NYHA class I-IV CHF or history of MI or stroke) or cerebrovascular conditions within 6 months before enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1cTimepoint: Baseline and 24 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in LDL CholesterolTimepoint: Baseline and 24 weeks;Change from baseline in Total CholesterolTimepoint: Baseline and 24 weeks;Change from baseline in TriglycerideTimepoint: Baseline and 24 weeks;Change from baseline in AdiponectinTimepoint: Baseline and 24 weeks;Change from baseline in BMITimepoint: Baseline and 24 weeks;Change from baseline in Fasting InsulinTimepoint: Baseline and 24 weeks;Change from baseline in Fasting Plasma Glucose <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Baseline and 24 weeks;Change from baseline in HDL CholesterolTimepoint: Baseline and 24 weeks;Change from baseline in hs-CRPTimepoint: Baseline and 24 weeks