To comapre the safety and efficacy of two antidiabetic drugs in treatment of patients with Type II diabetes
- Conditions
- Health Condition 1: null- Type-II diabetes patients
- Registration Number
- CTRI/2011/09/002024
- Lead Sponsor
- Abbott Healthcare Pvt td
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
1. >18 years of age, upper limit at the discretion of Investigator.
2.Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix B) at least 6 months prior to screening
3.Patients with type 2 diabetes mellitus who had previously received at least 3 months of continuous treatment with oral monotherapy of Metformin 1000 mg and is inadequately controlled [HbA1c > 8% and HbA1c < 11 %] during screening visit
4.Patient with BMI between 20 ? 35 Kg/m2
5.Patients whose baseline fasting plasma venous glucose (FPG) concentration ranging from >126mg/dl but < 200mg/dl
6.Patients whose venous plasma glucose concentration is > 200 mg/dl at 2hr postprandial (after a meal) but < 300mg/dl
7.Patients with stable dietary and exercise pattern since three month and willing to follow the same for entire trial duration.
8.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed.
1.Type-1 diabetes mellitus
2.Patients already on Insulin therapy.
3.H/O earlier use of dual or triple OAD¡¯s therapy.
4.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
5.Cardiac status New York Heart Association (NYHA) III-IV
6.Uncontrolled Blood pressure [ 140 Systolic and 90 Diastolic]
7.Impaired renal function as shown by, but not limited to, serum creatinine ¡Ý 1.5 mg/dL for males, or ¡Ý 1.4 mg/dL for females
8.Clinically significant peripheral edema
9.Acute infection
10.Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
11.Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range
12.Patients on steroids
13.Patient with anticipated need of surgery within study period.
14.Patient known to be suffering from any bleeding disorder.
15.Pregnancy or lactating women
16.Known hypersensitivity to any of the study drugs.
17.Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
18.Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
19.Diagnosis of dementia
20.Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
21.Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
22.Any disease or condition that in the opinion of the investigator may interfere with the completion of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method