Clinical trial NCT05659537: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Adult
GLP-1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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 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

Primary outcomes:
measure: Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths
timeFrame: Baseline through Follow-up (up to 28 weeks)
measure: Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.
timeFrame: Baseline through Follow-up (up to 28 weeks)
measure: Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24
timeFrame: Baseline through Week 24
measure: Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24
timeFrame: Baseline through Week 24
Secondary outcomes:
measure: Mean Change in HbA1c From Baseline to Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Medlink Hospital Opp Someshwara Jain Temple
state: Ambavadi
city: Bangalore
country: India
facility: Life Care Hospital and Research Centre
state: Karnataka
city: Pune
country: India
facility: Grant Medical Foundation - Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Akshay Hospital
state: Maharashtra
city: Wakad
country: India
facility: Lifepoint Multispecialty Hsptl
state: Pune
city: Coimbatore
country: India
facility: Kovai Diabetes Speciality Center and Hospital
state: Tamil Nadu
city: Hyderabad
country: India
facility: Virinchi Hospital
state: Telangana
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: