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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04809220
Collaborator
(none)
585
Enrollment
44
Locations
2
Arms
24.5
Anticipated Duration (Months)
13.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dulaglutide
  • Drug: Biguanide (BG)
  • Drug: Sulfonylurea (SU)
  • Drug: Alpha-Glucosidase Inhibitors (α-GI)
  • Drug: Thiazolidinedione (TZD)
  • Drug: Glinides (GLN)
  • Drug: Sodium-glucose cotransporter type 2 inhibitors (SGLT2i)
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
585 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 13, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Apr 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1.5 mg Dulaglutide

1.5 mg Dulaglutide given subcutaneously (SC). Dulaglutide will be given alone or in combination with 1 oral antihyperglycemic medications (OAM). Participants taking DPP-4 inhibitors (DPP-4i) to stop at randomization or if taking other OAM's, then continue taking same dose of OAM during the study period.

Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265

    • Drug: Biguanide (BG)
    Administered orally

    Drug: Sulfonylurea (SU)
    Pre-administered orally

    Drug: Alpha-Glucosidase Inhibitors (α-GI)
    Pre-administered orally

    Drug: Thiazolidinedione (TZD)
    Pre-administered orally

    Drug: Glinides (GLN)
    Pre-administered orally

    Drug: Sodium-glucose cotransporter type 2 inhibitors (SGLT2i)
    Pre-administered orally
    Active Comparator: 0.75 mg Dulaglutide

    0.75 mg Dulaglutide given SC. Dulaglutide will be given alone or in combination with 1 OAM. Participants taking DPP-4i to stop at randomization or if taking other OAM's, then continue taking same dose of OAM during the study period.

    Drug: Dulaglutide
    Administered SC
    Other Names:
  • LY2189265

    • Drug: Biguanide (BG)
    Administered orally

    Drug: Sulfonylurea (SU)
    Pre-administered orally

    Drug: Alpha-Glucosidase Inhibitors (α-GI)
    Pre-administered orally

    Drug: Thiazolidinedione (TZD)
    Pre-administered orally

    Drug: Glinides (GLN)
    Pre-administered orally

    Drug: Sodium-glucose cotransporter type 2 inhibitors (SGLT2i)
    Pre-administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 26]

      Change from Baseline in HbA1c

    Secondary Outcome Measures

    1. Change from Baseline in HbA1c [Baseline, Week 52]

      Change from Baseline in HbA1c

    2. Percentage of Participants Achieving HbA1c target ≤6.5% and < 7.0% [Baseline, Week 52]

      Percentage of Participants Achieving HbA1c target ≤6.5% and < 7.0%

    3. Change from Baseline in Fasting Serum Glucose (FSG) [Baseline, Week 52]

      Change from Baseline in FSG

    4. Change from baseline in 6-point Self-Monitored Blood Glucose (SMBG) [Baseline, Week 52]

      Change from baseline in 6-point SMBG

    5. Change from baseline in Body Weight [Baseline, Week 52]

      Change from baseline in Body Weight

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tosaki Clinic for Diabetes and Endocrinology Nagoya-shi Aichi Japan 468-0009
    2 Nakayama Clinic Nagoya Aichi Japan 456-0058
    3 Kashiwa City Hospital Kashiwa Chiba Japan 277-0825
    4 Kobari General Clinic Noda Chiba Japan 278-0004
    5 Nippon Kokan Fukuyama Hospital Fukuyama-shi Hiroshima Japan 721-0927
    6 Yamagata Naika Clinic Asahikawa Hokkaido Japan 078-8234
    7 Hasegawa Medical Clinic Chitose Hokkaido Japan 066-0032
    8 Yuri Ono Clinic Sapporo Hokkaido Japan 060-0001
    9 Manda Memorial Hospital Sapporo Hokkaido Japan 060-0062
    10 Miyanosawa Clinic of Internal Medicine and Cardiology Sapporo Hokkaido Japan 063-0826
    11 Takabe Diabetes Clinic Himeji Hyogo Japan 670-0837
    12 Nakamoto Internal Medicine Clinic Mito Ibaraki Japan 310-0826
    13 Nakakinen clinic Naka Ibaraki Japan 311-0113
    14 Nishiyamadou Keiwa Hospital Naka Ibaraki Japan 311-0133
    15 Hayashi Diabetes Internal Medicine Clinic Chigasaki Kanagawa Japan 253-0044
    16 Takai Internal Medicine Clinic Kamakura-shi Kanagawa Japan 247-0056
    17 Shonan Takai Clinic Kamakura Kanagawa Japan 247-0055
    18 Yamagishi Clinic Sagamiono Sagamihara Kanagawa Japan 252-0303
    19 Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Yamato-shi Kanagawa Japan 242-0004
    20 Seiryo Internal Medicine Iwanuma Miyagi Japan 989-2451
    21 Gibo Hepatology Clinic Matsumoto Nagano Japan 399-0036
    22 Shiraiwa Medical Clinic Kashiwara Osaka Japan 582-0005
    23 Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka Japan 565-0853
    24 Sugiura Internal Medicine Clinic Soka Saitama Japan 340-0034
    25 Seiwa Clinic Adachi-ku Tokyo Japan 120-0011
    26 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
    27 Medical Corporation Chiseikai Tokyo Center Clinic Chuo-ku Tokyo Japan 103-0028
    28 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    29 Hachioji Diabetes Clinic Hachioji Tokyo Japan 192-0083
    30 Minamino Cardiovascular Hospital Hachioji Tokyo Japan 192-0918
    31 Nomura Clinic Itabashi Tokyo Japan 173-0004
    32 Yutenji Medical Clinic Meguro-ku Tokyo Japan 153-0053
    33 Kanno Naika Mitaka Tokyo Japan 181-0013
    34 Heishinkai Medical Group ToCROM Clinic Shinjuku-ku Tokyo Japan 160-0008
    35 Futata Tetsuhiro Clinic Fukuoka Japan 810-0006
    36 Yoshimura Clinic Kumamoto Japan 861-8039
    37 Jinnouchi Hospital Kumamoto Japan 862-0976
    38 Heiwadai Hospital Miyazaki Japan 880-0034
    39 Ota Diabetes Internal Medicine Clinic Nagano Japan 380-0802
    40 Abe Clinic Oita Japan 870-0039
    41 AMC Nishiumeda Clinic Osaka Japan 530-0001
    42 Kitada Clinic Osaka Japan 538-0044
    43 Osaka City University Hospital Osaka Japan 545-8586
    44 Nanko Clinic Osaka Japan 559-0011

    Sponsors and Collaborators

    • Eli Lilly and Company

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04809220
    Other Study ID Numbers:
    • 17779
    • H9X-JE-GBGQ
    First Posted:
    Mar 22, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Metabolic Diseases
    Glucose Metabolism Disorders
    Endocrine System Diseases
    Dulaglutide
    Biguanides
    2,4-thiazolidinedione
    Glycoside Hydrolase Inhibitors

    Study Results

    No Results Posted as of Aug 18, 2022