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

August 24, 2023 updated by: Eli Lilly and Company

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

591

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Fukuoka, Japan, 810-0006
        • Futata Tetsuhiro Clinic
      • Kumamoto, Japan, 862-0976
        • Jinnouchi Hospital
      • Kumamoto, Japan, 861-8039
        • Yoshimura clinic
      • Miyazaki, Japan, 880-0034
        • Heiwadai Hospital
      • Nagano, Japan, 380-0802
        • Ota Diabetes Internal Medicine Clinic
      • Oita, Japan, 870-0039
        • Abe Clinic
      • Osaka, Japan, 538-0044
        • Kitada Clinic
      • Osaka, Japan, 530-0001
        • AMC Nishiumeda Clinic
      • Osaka, Japan, 545-8586
        • Osaka Metropolitan Univ Hosp
      • Osaka, Japan, 559-0011
        • Nanko Clinic
    • Aichi
      • Nagoya, Aichi, Japan, 456-0058
        • Nakayama Clinic
      • Nagoya-shi, Aichi, Japan, 468-0009
        • Tosaki Clinic for Diabetes and Endocrinology
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0825
        • Kashiwa City Hospital
      • Noda, Chiba, Japan, 278-0004
        • Kobari General Clinic
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 721-0927
        • Nippon Kokan Fukuyama Hospital
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8234
        • Yamagata Naika Clinic
      • Chitose, Hokkaido, Japan, 066-0032
        • Hasegawa Medical Clinic
      • Sapporo, Hokkaido, Japan, 060-0001
        • Yuri Ono Clinic
      • Sapporo, Hokkaido, Japan, 063-0826
        • Miyanosawa Clinic of Internal Medicine and Cardiology
      • Sapporo, Hokkaido, Japan, 060-0062
        • Manda Memorial Hospital
    • Hyogo
      • Himeji, Hyogo, Japan, 670-0837
        • Takabe Diabetes Clinic
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0826
        • Nakamoto Internal Medicine Clinic
      • Naka, Ibaraki, Japan, 311-0113
        • Nakakinen clinic
      • Naka, Ibaraki, Japan, 311-0133
        • Nishiyamadou Keiwa Hospital
    • Kanagawa
      • Chigasaki, Kanagawa, Japan, 253-0044
        • Hayashi Diabetes Internal Medicine Clinic
      • Kamakura, Kanagawa, Japan, 247-0055
        • Shonan Takai Clinic
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Takai Internal Medicine Clinic
      • Sagamihara, Kanagawa, Japan, 252-0303
        • Yamagishi Clinic Sagamiono
      • Yamato-shi, Kanagawa, Japan, 242-0004
        • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
    • Miyagi
      • Iwanuma, Miyagi, Japan, 989-2451
        • Seiryo Internal Medicine
    • Nagano
      • Matsumoto, Nagano, Japan, 399-0036
        • Gibo Hepatology Clinic
    • Osaka
      • Kashiwara, Osaka, Japan, 582-0005
        • Shiraiwa Medical Clinic
      • Suita-shi, Osaka, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Saitama
      • Soka, Saitama, Japan, 340-0034
        • Sugiura Internal Medicine Clinic
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 120-0011
        • Seiwa Clinic
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Fukuwa Clinic
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Medical Corporation Chiseikai Tokyo Center Clinic
      • Hachioji, Tokyo, Japan, 192-0918
        • Minamino Cardiovascular Hospital
      • Hachioji, Tokyo, Japan, 192-0083
        • Hachioji Diabetes Clinic
      • Itabashi, Tokyo, Japan, 173-0004
        • Nomura Clinic
      • Meguro-ku, Tokyo, Japan, 153-0053
        • Yutenji Medical Clinic
      • Mitaka, Tokyo, Japan, 181-0013
        • Kanno Naika
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Heishinkai Medical Group ToCROM Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dulaglutide 1.5 milligram (mg)
Participants received 1.5 mg of dulaglutide given weekly subcutaneously (SC) during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 oral antihyperglycemic medication (OAM). Participants on dipeptidyl peptidase-4 inhibitors (DPP-4i) discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
Administered SC
Other Names:
  • LY2189265
Administered orally
Active Comparator: Dulaglutide 0.75 mg
Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
Administered SC
Other Names:
  • LY2189265
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
Time Frame: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables.
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c at Week 52
Time Frame: Baseline, Week 52
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.
Baseline, Week 52
Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%
Time Frame: Week 52
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The odds ratios, confidence intervals, and p-values were determined by generalized linear mixed model (GLM) with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.
Week 52
Change From Baseline in Fasting Serum Glucose (FSG)
Time Frame: Baseline, Week 52
FSG is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment*Time as variables.
Baseline, Week 52
Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)
Time Frame: Baseline, Week 26
SMBG 6-point profiles were measured at morning (premeal-fasting, 2-hour post meal), midday (premeal, 2-hour post meal), and evening (premeal, 2-hour post meal). LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment as variables.
Baseline, Week 26
Change From Baseline in Body Weight
Time Frame: Baseline, Week 52
LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment*Time as variables.
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 17779
  • H9X-JE-GBGQ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glucose Metabolism Disorders

Clinical Trials on Dulaglutide

Subscribe