Safety and Efficacy of Exenatide Injection in Subjects with Type 2 Diabetes Mellitus: 24 Week Trial
- Conditions
- Health Condition 1: null- Type 2 diabetes mellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2013/01/003289
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 360
1.Male and female subjects 20 years of age and older.
2.Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
3.Weight stable
4.Women of child-bearing potential must be practicing an acceptable method of birth control as judged by the investigator
5.Willing to participate and give written informed consent.
1.Previous exposure to exenatide
2.Current or previous exposure to insulin.
3.Used drugs for weight loss
4.Currently treated with any of the excluded medications
5.Received treatment within the last 3 months with a drug that has not received regulatory approval for indication at the time of trial entry
6.Type 1 diabetes mellitus.
7.Severe renal impairment
8.A history of renal transplantation or currently on renal dialysis.
9.History of pancreatitis.
10.A known allergy to any components contained in the exenatide injection.
11.A history of severe gastrointestinal disease
12.Pregnant or lactating females
13.History of chronic pancreatitis
14.Immunosuppressed or requiring treatment with an immunosuppressant or recently received an immunosuppressant, including systemic corticosteroids.
15.History of immune deficiency syndrome or HIV positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method