A clinical trial to study the effect of Teneligliptin Tablet in the treatment of patients with Type 2 Diabetes Mellitus Inadequately Controlled with diet and exercise.
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise Alone
- Registration Number
- CTRI/2014/01/004315
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 237
1. Type 2 Diabetes Mellitus patients aged >=18 to <=65 years inclusive of either sex
2. Patient with inadequate glycaemic control [glycosylated haemoglobin (HbA1c) >7% to <=8.5%] with diet and exercise therapy alone and treatment naive.
3. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
4. Patients willing to comply with the protocol requirements.
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. Patients with known hypersensitivity to any of the components of the formulation
4. 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.
5. Patients who have a recent history or who are currently known to abuse alcohol or drugs.
6. Patients with clinically significant renal, hepatic, or cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infection etc. or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
7. Patients receiving treatment with systemic corticosteroids.
8. Patients who have participated in any clinical trial in the past 1 month.
9. 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: 16 weeks
- Secondary Outcome Measures
Name Time Method Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)Timepoint: 16 weeks;Proportion of patients achieving the goal of HbA1c â?¤7% levelTimepoint: 16 weeks