Study to evaluate safety of dulaglutide in patients with Type 2 diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/12/048337
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Are 18 years of age or older and an Indian resident.
2. Have been diagnosed with T2D for at least 1 year and are being currently treated with oral antidiabetic medicines and/or insulins that are allowed in the study.
3. HbA1c value is = 7.5 % and = 11.5 % at Visit 1.
1. Have been diagnosed with any type of diabetes other than T2D.
2. Have any kidney, liver, gastrointestinal, or pancreatic diseases that are not allowed in the study.
3. Have certain cancers that are not allowed in the study.
4. Have been treated with certain medicines that are not allowed in the study within 3 months before screening.
5. Have a known hypersensitivity or allergy to the study medicine or its inactive constituents.
6. Are overweight and are a candidate for certain surgeries that are not allowed in the study.
7. Are a woman who can get pregnant and are not willing to use an appropriate birth control method during the study.
8. Are a woman who is pregnant or breastfeeding.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the safety profile of 1.5 and 0.75 mg dulaglutide in patients with T2DM in India.Timepoint: 1. Incidence of AEs between baseline to Week 24. <br/ ><br>2. Proportion of patients reporting AEs and SAEs between baseline to Week 24. <br/ ><br>3. Incidence of GI AEs between baseline to Week 24.
- Secondary Outcome Measures
Name Time Method 1. Change in HbA1c for pooled doses of dulaglutide. <br/ ><br>2. Change in body weight. <br/ ><br>3. Change in FBG. <br/ ><br>4. Change in vital signs.Timepoint: Baseline to Week 24