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A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Dulaglutide
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Adult, GLP-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have a diagnosis of type 2 diabetes mellitus (T2DM) of at least 1-year duration currently treated with stable doses of oral antihyperglycemic medications with or without stable doses of basal or premix insulin for the last 3 months prior to screening. Have HbA1c ≥7.5% and ≤11.5%, both inclusive, at screening, and Have body mass index (BMI) ≥23 kilogram/square meter (kg/m²) Exclusion Criteria: A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM Been treated with antihyperglycemic medication like glucagon-like peptide receptor agonists (GLP-1 RA) or have a prior history of any contraindication to GLP-1 RA therapy within 3 months prior to screening, or eGFR <15 milliliter/minute (ml/min)/1.73 square meter (m²) Participants have known hypersensitivity or allergy to dulaglutide or its excipients. Participants are on systemic steroids for any period of more than 14 days. Participants have severe gastrointestinal (GI) disease, including severe gastroparesis. Participants have an active or untreated malignancy, except for successfully treated basal or squamous cell carcinoma.

Sites / Locations

  • Medlink Hospital Opp Someshwara Jain Temple
  • V.S. General Hospital
  • B. J. Medical College & Civil Hospital
  • Life Care Hospital and Research Centre
  • Grant Medical Foundation - Ruby Hall Clinic
  • Akshay Hospital
  • Lifepoint Multispecialty Hsptl
  • Bhandari Clinic & Research Centre
  • Eternal Heart Care Center and Research Institute
  • Kovai Diabetes Speciality Center and Hospital
  • Virinchi Hospital
  • Medical College & Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dulaglutide

Arm Description

Participants will receive dulaglutide subcutaneously (SC)

Outcomes

Primary Outcome Measures

Incidence of Gastrointestinal (GI) Adverse Events
Incidence of Death, Serious Adverse Event(s), AEs and Treatment Emergent Adverse Events (TEAEs)
Incidence of Hypoglycemia including Severe Hypoglycemia
Percentage of Participants with AEs and SAEs

Secondary Outcome Measures

Mean Change from Baseline in Hemoglobin A1c (HbA1c)

Full Information

First Posted
December 15, 2022
Last Updated
October 17, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05659537
Brief Title
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India
Official Title
A 24-week Multicenter, Open-label, Single-arm Study to Evaluate Safety in Patients With Type 2 Diabetes Mellitus in India Treated With Dulaglutide
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 29, 2022 (Actual)
Primary Completion Date
January 25, 2024 (Anticipated)
Study Completion Date
January 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Adult, GLP-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dulaglutide
Arm Type
Experimental
Arm Description
Participants will receive dulaglutide subcutaneously (SC)
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
LY2189265
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Incidence of Gastrointestinal (GI) Adverse Events
Time Frame
Baseline up to Week 24
Title
Incidence of Death, Serious Adverse Event(s), AEs and Treatment Emergent Adverse Events (TEAEs)
Time Frame
Baseline up to Week 24
Title
Incidence of Hypoglycemia including Severe Hypoglycemia
Time Frame
Baseline up to Week 24
Title
Percentage of Participants with AEs and SAEs
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of type 2 diabetes mellitus (T2DM) of at least 1-year duration currently treated with stable doses of oral antihyperglycemic medications with or without stable doses of basal or premix insulin for the last 3 months prior to screening. Have HbA1c ≥7.5% and ≤11.5%, both inclusive, at screening, and Have body mass index (BMI) ≥23 kilogram/square meter (kg/m²) Exclusion Criteria: A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM Been treated with antihyperglycemic medication like glucagon-like peptide receptor agonists (GLP-1 RA) or have a prior history of any contraindication to GLP-1 RA therapy within 3 months prior to screening, or eGFR <15 milliliter/minute (ml/min)/1.73 square meter (m²) Participants have known hypersensitivity or allergy to dulaglutide or its excipients. Participants are on systemic steroids for any period of more than 14 days. Participants have severe gastrointestinal (GI) disease, including severe gastroparesis. Participants have an active or untreated malignancy, except for successfully treated basal or squamous cell carcinoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Medlink Hospital Opp Someshwara Jain Temple
City
Ahmedabad
State/Province
Ambavadi
ZIP/Postal Code
380015
Country
India
Facility Name
V.S. General Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
B. J. Medical College & Civil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Life Care Hospital and Research Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Facility Name
Grant Medical Foundation - Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Akshay Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Lifepoint Multispecialty Hsptl
City
Wakad
State/Province
Pune
ZIP/Postal Code
411057
Country
India
Facility Name
Bhandari Clinic & Research Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302015
Country
India
Facility Name
Eternal Heart Care Center and Research Institute
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Kovai Diabetes Speciality Center and Hospital
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641009
Country
India
Facility Name
Virinchi Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
50034
Country
India
Facility Name
Medical College & Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700073
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/

Learn more about this trial

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

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