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Diabetes MellitusPhase 3AWARD-JPNNCT04809220

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

A Phase 3 study testing Dulaglutide and Oral antihyperglycemics in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 44 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Dulaglutide and Oral antihyperglycemics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
591 participants
Where
44 sitesJapan
Study dates
13 Apr 2021to 26 Apr 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

Japan44 sites

  • Seiwa Clinic

    Adachi-ku, Tokyo, 120-0011

  • Yamagata Naika Clinic

    Asahikawa, Hokkaido, 078-8234

  • Hayashi Diabetes Internal Medicine Clinic

    Chigasaki, Kanagawa, 253-0044

  • Hasegawa Medical Clinic

    Chitose, Hokkaido, 066-0032

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0028

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Futata Tetsuhiro Clinic

    Fukuoka, 810-0006

  • Nippon Kokan Fukuyama Hospital

    Fukuyama-shi, Hiroshima, 721-0927

  • Hachioji Diabetes Clinic

    Hachiōji, Tokyo, 192-0083

  • Minamino Cardiovascular Hospital

    Hachiōji, Tokyo, 192-0918

  • Takabe Diabetes Clinic

    Himeji, Hyōgo, 670-0837

  • Seiryo Internal Medicine

    Iwanuma, Miyagi, 989-2451

  • Shonan Takai Clinic

    Kamakura, Kanagawa, 247-0055

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa, 247-0056

  • Shiraiwa Medical Clinic

    Kashihara, Osaka, 582-0005

  • Kashiwa City Hospital

    Kashiwa, Chiba, 277-0825

  • Yoshimura Clinic

    Kumamoto, 861-8039

  • Jinnouchi Hospital

    Kumamoto, 862-0976

  • Gibo Hepatology Clinic

    Matsumoto, Nagano, 399-0036

  • Yutenji Medical Clinic

    Meguro-ku, Tokyo, 153-0053

  • Kanno Naika

    Mitaka, Tokyo, 181-0013

  • Nakamoto Internal Medicine Clinic

    Mito, Ibaraki, 310-0826

  • Heiwadai Hospital

    Miyazaki, 880-0034

  • Ota Diabetes Internal Medicine Clinic

    Nagano, 380-0802

  • Nakayama Clinic

    Nagoya, Aichi-ken, 456-0058

  • Tosaki Clinic for Diabetes and Endocrinology

    Nagoya, Aichi-ken, 468-0009

  • Nakakinen clinic

    Naka, Ibaraki, 311-0113

  • Nishiyamadou Keiwa Hospital

    Naka, Ibaraki, 311-0133

  • Kobari General Clinic

    Noda, Chiba, 278-0004

  • Abe Clinic

    Ōita, 870-0039

  • AMC Nishiumeda Clinic

    Osaka, 530-0001

  • Kitada Clinic

    Osaka, 538-0044

  • Osaka Metropolitan Univ Hosp

    Osaka, 545-8586

  • Nanko Clinic

    Osaka, 559-0011

  • Yamagishi Clinic Sagamiono

    Sagamihara, Kanagawa, 252-0303

  • Yuri Ono Clinic

    Sapporo, Hokkaido, 060-0001

  • Manda Memorial Hospital

    Sapporo, Hokkaido, 060-0062

  • Miyanosawa Clinic of Internal Medicine and Cardiology

    Sapporo, Hokkaido, 063-0826

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008

  • Sugiura Internal Medicine Clinic

    Sōka, Saitama, 340-0034

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853

  • Nomura Clinic

    tabashi City, Tokyo, 173-0004

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa, 242-0004

Other trials in Japan

About this study

Official title: 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.

Being tested
Dulaglutide, Oral antihyperglycemics
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DulaglutideDrug

    Also called LY2189265

    Administered SC

  • Oral antihyperglycemicsDrug

    Administered orally

Study groups in NCT04809220
Study groupRoleWhat they receive
Dulaglutide 1.5 milligram (mg)ExperimentalParticipants 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.
Receives: Drug: Dulaglutide; Drug: Oral antihyperglycemics
Dulaglutide 0.75 mgActive comparatorParticipants 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.
Receives: Drug: Dulaglutide; Drug: Oral antihyperglycemics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at 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.

    Measured: Baseline, Week 26

Secondary outcomes (5)

  1. Change From Baseline in HbA1c at 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.

    Measured: Baseline, Week 52

  2. Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%

    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.

    Measured: Week 52

  3. Change From Baseline in Fasting Serum Glucose (FSG)

    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.

    Measured: Baseline, Week 52

  4. Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)

    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.

    Measured: Baseline, Week 26

  5. Change From Baseline in Body Weight

    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.

    Measured: Baseline, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start13 Apr 2021
  3. Primary completion1 Oct 2022
  4. Study completion26 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
591 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04809220
Sponsor's protocol ID
17779
Other IDs
H9X-JE-GBGQ
Acronym
AWARD-JPN
Status last verified
Apr 2024
First submitted
19 Mar 2021
Last updated
22 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dulaglutide and Oral antihyperglycemics in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 44 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04809220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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