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

A 24-week Multicenter, Open-label, Single-arm Study to Evaluate Safety in Patients With Type 2 Diabetes Mellitus in India Treated With Dulaglutide

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Dulaglutide

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Ambavadi
    • Ahmedabad, Ambavadi, India, 380015
      • Medlink Hospital Opp Someshwara Jain Temple
  • Karnataka
    • Bangalore, Karnataka, India, 560092
      • Life Care Hospital and Research Centre
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Grant Medical Foundation - Ruby Hall Clinic
    • Pune, Maharashtra, India, 411004
      • Akshay Hospital
  • Pune
    • Wakad, Pune, India, 411057
      • Lifepoint Multispecialty Hsptl
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641009
      • Kovai Diabetes Speciality Center and Hospital
  • Telangana
    • Hyderabad, Telangana, India, 50034
      • Virinchi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 hemoglobin A1c (HbA1c) greater than or equal to (≥) 7.5 percent (%) and less than or equal to (≤) 11.5%, both inclusive, at screening
• 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 estimated glomerular filtration rate (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dulaglutide; Participants received once-weekly (QW) subcutaneous (SC) dulaglutide injections for 24 weeks, starting with either 1.5 milligrams (mg) as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator).; For participants reporting gastrointestinal adverse events (GI AEs) after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced.

Drug: Dulaglutide; Administered SC; Other Names: LY2189265

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths	An AE was any untoward medical occurrence in a participant who was administered an investigational product that did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE that occurred post-dose or was present prior to dosing and became more severe post-dose.; An SAE was any AE from the study that resulted in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that might not have been immediately life-threatening or resulted in death or hospitalization but might have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.; A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.	Baseline through Follow-up (up to 28 weeks)
Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.	Hypoglycemia events were defined as those with blood glucose (BG) levels less than (<) 70 milligrams per deciliter (mg/dL). Severe hypoglycemia events were defined as those with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. These events could be associated with sufficient neuroglycopenia to induce seizures or coma. The total number of participants who experienced hypoglycemia events, including severe hypoglycemia, was summarized cumulatively.	Baseline through Follow-up (up to 28 weeks)
Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24	The percentage of participants who reported AEs and SAEs was calculated by dividing the total number of affected participants by the number of participants analyzed, then multiplying by 100. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.	Baseline through Week 24
Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24	The number of participants who experienced at least one or more GI AEs of nausea, vomiting, and diarrhoea were summarized cumulatively. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.	Baseline through Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in HbA1c From Baseline to Week 24	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The mean change in HbA1c levels was calculated using descriptive analysis, with baseline HbA1c as a covariate. Missing endpoints were addressed using the last observation carried forward (LOCF) method.	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Actual): January 16, 2024
• Study Completion (Actual): January 16, 2024

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: GLP-1; Adult
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; Dulaglutide
• Other Study ID Numbers: 18550; H9X-IN-GBGR (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No