A clinical trial to study the effect of Fixed Dose Combination of Teneligliptin and Metformin Tablet in the treatment of patients with Type 2 Diabetes Mellitus.
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone.
- Registration Number
- CTRI/2014/08/004827
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 378
1. Patients age >=18 and <=65 years inclusive of either sex willing to give their written informed consent and comply with the protocol requirements.
2. Patients with Type 2 Diabetes Mellitus who have been treated with upto 1 gram per day of Metformin monotherapy for at least 3 months prior to screening and having inadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) levels of >7% to <= 9%].
1. Pregnant or lactating women.
2. Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
3. Patient with Type 1 diabetes mellitus or secondary form of diabetes.
4. Patients with known hypersensitivity to any of the components of the formulation.
5. Known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe Peripheral Neuropathy, Symptomatic Orthostatic Hypotension, Urinary Retention, Foot ulcers, or Gastric Stasis.
6. Patients who have a recent history or who are currently known to abuse alcohol or drugs.
7. Patients with clinically significant renal, hepatic, or cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, collagen disorders, severe infection etc. or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
8. Patients receiving treatment with systemic corticosteroids.
9. Patients who have participated in any clinical trial in the past 1 month.
10. Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Change in Glycosylated Haemoglobin (HbA1c) levelsTimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)Timepoint: 24 weeks;Proportion of patients achieving the goal of HbA1c â?¤7% levelTimepoint: 24 weeks