To compare the safety and effectiveness of teneligliptin with vildagliptin in patients of uncontrolled type 2 diabetes mellitus ,already on metformin drug.
Phase 4
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/05/019345
- Lead Sponsor
- Dr Arun Kumar Negi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. All willing patients of either sex.
2. Patients with type 2 diabetes mellitus (T2DM).
3. Patients with uncontrolled T2DM on 2 gram metformin dose.
4. Patients having HbA1c level >=7 %.
5. Patients fasting plasma glucose (FPG) levels >= 126 mg/dL or post prandial glucose (PPG) >= 200 mg/dL.
Exclusion Criteria
1. All unwilling patients.
2. Acute complications of diabetes
i. Hyperglycemic hyperosmolar state
ii. Diabetic ketoacidosis
3. Liver Disease
4. Congestive heart failure
5. Acute coronary syndrome
6. Pregnancy and lactating mothers
7. Known hypersensitivity to study drugs
8. Patients already on study drugs
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycosylated hemoglobin (HbA1c).Timepoint: After one month,three and six months of enrollment.
- Secondary Outcome Measures
Name Time Method Fasting Blood sugar (FBS). <br/ ><br>Post prandial blood sugar (PPBS).Timepoint: After one month,three month and six months of enrollment.