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

NCT05659537 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 18550H9X-IN-GBGR
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

Adult; GLP-1

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Mean Change in HbA1c From Baseline to Week 24

  Baseline, Week 24

Study Arms (1)

Dulaglutide

EXPERIMENTAL

* 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

Interventions

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

Dulaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (7)

Medlink Hospital Opp Someshwara Jain Temple

Ahmedabad, Ambavadi, 380015, India

Location

Life Care Hospital and Research Centre

Bangalore, Karnataka, 560092, India

Location

Grant Medical Foundation - Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Akshay Hospital

Pune, Maharashtra, 411004, India

Location

Lifepoint Multispecialty Hsptl

Wakad, Pune, 411057, India

Location

Kovai Diabetes Speciality Center and Hospital

Coimbatore, Tamil Nadu, 641009, India

Location

Virinchi Hospital

Hyderabad, Telangana, 50034, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 21, 2022
• Study Start: December 29, 2022
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: February 20, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

IN (7)