Status:
COMPLETED
A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.
Eligibility Criteria
Inclusion
- Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.
- Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.
- Have the following HbA1c result at screening.
- Participants taking DPP-4i: ≥7.5% and ≤9.5%,
- Participants taking another OAM: ≥8.0% and ≤10.0%
- Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks
- Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and \<35 kg/m² at Day 1.
Exclusion
- Have type 1 diabetes (T1D)
- Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
- Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
- Have a known clinically significant gastric empty abnormality
- Have acute or chronic hepatitis
- Have had chronic or acute pancreatitis
- Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
- Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)
- Have evidence of significant, active autoimmune abnormality
- Have evidence of significant, uncontrolled endocrine abnormality
- Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
- Have any hematologic condition that may interfere with HbA1c measurement
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
591 Patients enrolled
Trial Details
Trial ID
NCT04809220
Start Date
April 13 2021
End Date
April 26 2023
Last Update
May 22 2024
Active Locations (44)
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1
Nakayama Clinic
Nagoya, Aichi-ken, Japan, 456-0058
2
Tosaki Clinic for Diabetes and Endocrinology
Nagoya, Aichi-ken, Japan, 468-0009
3
Kashiwa City Hospital
Kashiwa, Chiba, Japan, 277-0825
4
Kobari General Clinic
Noda, Chiba, Japan, 278-0004