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Study on Type 2 Diabetes Mellitus patients in India being started on Dulaglutide

A 24 week Prospective Non-Interventional Post-Marketing Surveillance Study on Adverse Events and Serious Adverse Events in Patients with Type 2 Diabetes Mellitus in India being started on Dulaglutide (Trulicity™)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/07/015003
Enrollment
400
Registered
2018-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: null- Patients with Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: There are no treatment groups for this study. The patient population for this study will consist of patients with type 2 diabetes mellitus being started on dulaglutide as per the approv

Sponsors

Eli Lilly and Company India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Provide written consent (consent to release information) for this study, 2.diagnosed with type 2 diabetes mellitus 3.have a baseline HbA1c =10% (as per the lab report from the last 60 days) 4.have never been treated by dulaglutide 5.is determined by the investigator before enrollment that the patient is appropriate to be treated with dulaglutide

Exclusion criteria

Exclusion criteria: 1.Are investigator site personnel directly affiliated with the study, and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted 2.Are employed by Lilly (i.e. employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored or Lilly-managed clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined above. 3.Are simultaneously participating in a clinical trial that includes a treatment intervention and/or dulaglutide 4.Have any contraindication to dulaglutide 5.Are pregnant or lactating mothers

Design outcomes

Primary

MeasureTime frame
Safety of patientTimepoint: Safety assessment will be done at the end of 24 weeks

Secondary

MeasureTime frame
Complaint HandlingTimepoint: Product Complaint assessment will be done at the end of 24 weeks

Countries

India

Contacts

Public ContactDr Rajeev Sharan Shrivastava

Eli Lilly and Company (India) Pvt. Ltd.

manish.mistry@lilly.com9820234897

Outcome results

None listed

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