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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659537
• Other study ID #: 18550
• Secondary ID: H9X-IN-GBGR
• Status: Completed
• Phase: Phase 4
• Start date: December 29, 2022
• Est. completion date: January 16, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 16, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dulaglutide
Administered SC

Locations

Country	Name	City	State
India	Medlink Hospital Opp Someshwara Jain Temple	Ahmedabad	Ambavadi
India	Life Care Hospital and Research Centre	Bangalore	Karnataka
India	Kovai Diabetes Speciality Center and Hospital	Coimbatore	Tamil Nadu
India	Virinchi Hospital	Hyderabad	Telangana
India	Akshay Hospital	Pune	Maharashtra
India	Grant Medical Foundation - Ruby Hall Clinic	Pune	Maharashtra
India	Lifepoint Multispecialty Hsptl	Wakad	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Gastrointestinal (GI) Adverse Events		Baseline up to Week 24
Primary	Incidence of Death, Serious Adverse Event(s), AEs and Treatment Emergent Adverse Events (TEAEs)		Baseline up to Week 24
Primary	Incidence of Hypoglycemia including Severe Hypoglycemia		Baseline up to Week 24
Primary	Percentage of Participants with AEs and SAEs		Week 24
Secondary	Mean Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 24