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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05659537
Collaborator
(none)
200
Enrollment
1
Arm
9.6
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 23, 2022
Anticipated Primary Completion Date :
Oct 11, 2023
Anticipated Study Completion Date :
Oct 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dulaglutide

Participants will receive dulaglutide subcutaneously (SC)

Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Gastrointestinal (GI) Adverse Events [Baseline up to Week 24]

    2. Incidence of Death, Serious Adverse Event(s), AEs and Treatment Emergent Adverse Events (TEAEs) [Baseline up to Week 24]

    3. Incidence of Hypoglycemia including Severe Hypoglycemia [Baseline up to Week 24]

    4. Percentage of Participants with AEs and SAEs [Week 24]

    Secondary Outcome Measures

    1. Mean Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05659537
    Other Study ID Numbers:
    • 18550
    • H9X-IN-GBGR
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Dec 21, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Adult
    GLP-1
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Dulaglutide

    Study Results

    No Results Posted as of Dec 21, 2022