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

  • STATUS
    Recruiting
  • End date
    Apr 29, 2023
  • participants needed
    585
  • sponsor
    Eli Lilly and Company
Updated on 29 July 2022
body mass index
hemoglobin a1c
sulfonylurea
alpha-glucosidase inhibitor

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.

Details
Condition Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Hypoglycemic Agents, Type 2 Diabetes Mellitus (T2DM)
Treatment Dulaglutide, Biguanide (BG), Sulfonylurea (SU), Alpha-Glucosidase Inhibitors (α-GI), Thiazolidinedione (TZD), Glinides (GLN), Sodium-glucose cotransporter type 2 inhibitors (SGLT2i)
Clinical Study IdentifierNCT04809220
SponsorEli Lilly and Company
Last Modified on29 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
% 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 Criteria

Have type 1 diabetes (T1D)
Have a history of ≥1 episode of ketoacidosis or hyperosmola 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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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