Study to evaluate safety of dulaglutide in patients with Type 2 diabetes

A 24-week multicenter, open-label, single-arm study to evaluate safety in patients with type 2 diabetes mellitus in India treated with dulaglutide

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/12/048337

Enrollment

200

Registered

2022-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Dulaglutide: 0.75 mg or 1.5 mg of Dulaglutide injected subcutaneously once weekly. The study will last about 30 weeks. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. 2. Proportion of patients reporting AEs and SAEs between baseline to Week 24. 3. Incidence of GI AEs between baseline to Week 24.	—

Secondary

Measure	Time frame
1. Change in HbA1c for pooled doses of dulaglutide. 2. Change in body weight. 3. Change in FBG. 4. Change in vital signs.Timepoint: Baseline to Week 24	—

Countries

India

Contacts

Public ContactDr Rajeev Sharan Shrivastava

Eli Lilly and Company (India) Pvt. Ltd.

arora_rohit@lilly.com9820234897

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026