This study is done to assess Effectiveness and Safety study of a three drug combination with a two drug combination for the treatment of type 2 diabetes mellitus in patients who have never received insulin.
- Conditions
- Health Condition 1: null- Treatment in insulin-naïve patients with type 2 diabetes
- Registration Number
- CTRI/2011/06/001841
- Lead Sponsor
- Abbott India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 70
Subjects meeting all of the following criteria will be considered for enrollment into the study
-Subjects or their legally-acceptable representatives (LARs) must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
-18 years of age, upper limit at the discretion of Investigator.
-Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix A) at least 6months prior to screening.
-HbA1C greater than 8%
-Insulin naive
-Patients who are either not receiving or are on a constant dose of lipid lowering agent/s since last three months.
-Patients with stable dietary and exercise pattern since three months and willing to follow the same for the entire trial duration.
(There is no upper limit to age)
-Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
Cardiac status New York Heart Association (NYHA) III-IV
Impaired renal function as shown by, but not limited to, serum creatinine more than or equal to 1.5 mg/dL for males, more than or equal to 1.4 mg/dL for females
Use of Oral hypoglycemic agent in the past 3 months
Acute infection
Clinically significant peripheral edema
Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
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
History of hypoglycemia unawareness
Pregnancy or lactation
Known hypersensitivity to any Oral hypoglycemic agent.
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
Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
Diagnosis of dementia
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
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
Indications of Insulin in Type 2 Diabetes
At onset, if FBG is 250 mg/dl and/or ketonuria. In stressful situations (acute myocardial infarction, stroke, fulminant infections, trauma). During pregnancy. Perioperative state. Hepatic and renal decompensation. Diabetic coma Idiosyncrasies to oral anti-diabetic agents. Secondary failure to OHA. Diabetics on steroids
Any disease or condition that in the opinion of the investigator and/or sponsor 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