Back to resultsA Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes (AWARD-JPN)
Primary Purpose
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Dulaglutide
Oral antihyperglycemics
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
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 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
Sites / Locations
- Tosaki Clinic for Diabetes and Endocrinology
- Nakayama Clinic
- Kashiwa City Hospital
- Kobari General Clinic
- Nippon Kokan Fukuyama Hospital
- Yamagata Naika Clinic
- Hasegawa Medical Clinic
- Yuri Ono Clinic
- Manda Memorial Hospital
- Miyanosawa Clinic of Internal Medicine and Cardiology
- Takabe Diabetes Clinic
- Nakamoto Internal Medicine Clinic
- Nakakinen clinic
- Nishiyamadou Keiwa Hospital
- Hayashi Diabetes Internal Medicine Clinic
- Takai Internal Medicine Clinic
- Shonan Takai Clinic
- Yamagishi Clinic Sagamiono
- Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
- Seiryo Internal Medicine
- Gibo Hepatology Clinic
- Shiraiwa Medical Clinic
- Medical Corporation Heishinkai OCROM Clinic
- Sugiura Internal Medicine Clinic
- Seiwa Clinic
- Tokyo-Eki Center-building Clinic
- Medical Corporation Chiseikai Tokyo Center Clinic
- Fukuwa Clinic
- Hachioji Diabetes Clinic
- Minamino Cardiovascular Hospital
- Nomura Clinic
- Yutenji Medical Clinic
- Kanno Naika
- Heishinkai Medical Group ToCROM Clinic
- Futata Tetsuhiro Clinic
- Yoshimura Clinic
- Jinnouchi Hospital
- Heiwadai Hospital
- Ota Diabetes Internal Medicine Clinic
- Abe Clinic
- AMC Nishiumeda Clinic
- Kitada Clinic
- Osaka Metropolitan Univ Hosp
- Nanko Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dulaglutide 1.5 milligram (mg)
Dulaglutide 0.75 mg
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04809220
Brief Title
A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
Acronym
AWARD-JPN
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
April 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Hypoglycemic Agents, Type 2 Diabetes Mellitus (T2DM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
591 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dulaglutide 1.5 milligram (mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
Dulaglutide 0.75 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
LY2189265
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Oral antihyperglycemics
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
Description
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.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Week 52
Description
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.
Time Frame
Baseline, Week 52
Title
Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%
Description
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.
Time Frame
Week 52
Title
Change From Baseline in Fasting Serum Glucose (FSG)
Description
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.
Time Frame
Baseline, Week 52
Title
Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)
Description
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.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Body Weight
Description
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.
Time Frame
Baseline, Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Tosaki Clinic for Diabetes and Endocrinology
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
468-0009
Country
Japan
Facility Name
Nakayama Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
456-0058
Country
Japan
Facility Name
Kashiwa City Hospital
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0825
Country
Japan
Facility Name
Kobari General Clinic
City
Noda
State/Province
Chiba
ZIP/Postal Code
278-0004
Country
Japan
Facility Name
Nippon Kokan Fukuyama Hospital
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
721-0927
Country
Japan
Facility Name
Yamagata Naika Clinic
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8234
Country
Japan
Facility Name
Hasegawa Medical Clinic
City
Chitose
State/Province
Hokkaido
ZIP/Postal Code
066-0032
Country
Japan
Facility Name
Yuri Ono Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Manda Memorial Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0062
Country
Japan
Facility Name
Miyanosawa Clinic of Internal Medicine and Cardiology
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0826
Country
Japan
Facility Name
Takabe Diabetes Clinic
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-0837
Country
Japan
Facility Name
Nakamoto Internal Medicine Clinic
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0826
Country
Japan
Facility Name
Nakakinen clinic
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
Nishiyamadou Keiwa Hospital
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0133
Country
Japan
Facility Name
Hayashi Diabetes Internal Medicine Clinic
City
Chigasaki
State/Province
Kanagawa
ZIP/Postal Code
253-0044
Country
Japan
Facility Name
Takai Internal Medicine Clinic
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Shonan Takai Clinic
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-0055
Country
Japan
Facility Name
Yamagishi Clinic Sagamiono
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0303
Country
Japan
Facility Name
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
City
Yamato-shi
State/Province
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Facility Name
Seiryo Internal Medicine
City
Iwanuma
State/Province
Miyagi
ZIP/Postal Code
989-2451
Country
Japan
Facility Name
Gibo Hepatology Clinic
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
399-0036
Country
Japan
Facility Name
Shiraiwa Medical Clinic
City
Kashiwara
State/Province
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Sugiura Internal Medicine Clinic
City
Soka
State/Province
Saitama
ZIP/Postal Code
340-0034
Country
Japan
Facility Name
Seiwa Clinic
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
120-0011
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Medical Corporation Chiseikai Tokyo Center Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Hachioji Diabetes Clinic
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0083
Country
Japan
Facility Name
Minamino Cardiovascular Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Nomura Clinic
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
173-0004
Country
Japan
Facility Name
Yutenji Medical Clinic
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-0053
Country
Japan
Facility Name
Kanno Naika
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Facility Name
Heishinkai Medical Group ToCROM Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Futata Tetsuhiro Clinic
City
Fukuoka
ZIP/Postal Code
810-0006
Country
Japan
Facility Name
Yoshimura Clinic
City
Kumamoto
ZIP/Postal Code
861-8039
Country
Japan
Facility Name
Jinnouchi Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Heiwadai Hospital
City
Miyazaki
ZIP/Postal Code
880-0034
Country
Japan
Facility Name
Ota Diabetes Internal Medicine Clinic
City
Nagano
ZIP/Postal Code
380-0802
Country
Japan
Facility Name
Abe Clinic
City
Oita
ZIP/Postal Code
870-0039
Country
Japan
Facility Name
AMC Nishiumeda Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Kitada Clinic
City
Osaka
ZIP/Postal Code
538-0044
Country
Japan
Facility Name
Osaka Metropolitan Univ Hosp
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Nanko Clinic
City
Osaka
ZIP/Postal Code
559-0011
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Learn more about this trial
A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
We'll reach out to this number within 24 hrs