A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes (AWARD-JPN )

JRCT ID: jRCT2031210019

Registered date:06/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 13/04/2021
• Target sample size: 585
• Study type: Interventional

Intervention(s)

Experimental: 1.5 mg Dulaglutide
Active Comparator: 0.75 mg Dulaglutide

Outcome(s)

• Primary Outcome: Change from Baseline in HbA1c at Week 26

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participants with type 2 diabetes (T2D) for 6 months or more 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: between 7.5% to 9.5%,
-Participants taking another OAM: between 8.0% to 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) equal to or more than 18.5 kilogram/square meter (kg/m2) and less than 35 kg/m2 at Day 1.

Exclude criteria

-Have type 1 diabetes (T1D)
-Have a history of >=1 episode of ketoacidosis or hypersmolar 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 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

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT04809220