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

Diabetes Mellitus, Type 2 Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809220
• Other study ID #: 17779
• Secondary ID: H9X-JE-GBGQ
• Status: Completed
• Phase: Phase 3
• Start date: April 13, 2021
• Est. completion date: April 26, 2023

Study information

• Verified date: August 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: April 26, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Hypoglycemic Agents
• Metabolic Disease
• Metabolic Diseases
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• Dulaglutide
Administered SC
• Oral antihyperglycemics
Administered orally

Locations

Country	Name	City	State
Japan	Seiwa Clinic	Adachi-ku	Tokyo
Japan	Yamagata Naika Clinic	Asahikawa	Hokkaido
Japan	Hayashi Diabetes Internal Medicine Clinic	Chigasaki	Kanagawa
Japan	Hasegawa Medical Clinic	Chitose	Hokkaido
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Medical Corporation Chiseikai Tokyo Center Clinic	Chuo-ku	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	Futata Tetsuhiro Clinic	Fukuoka
Japan	Nippon Kokan Fukuyama Hospital	Fukuyama-shi	Hiroshima
Japan	Hachioji Diabetes Clinic	Hachioji	Tokyo
Japan	Minamino Cardiovascular Hospital	Hachioji	Tokyo
Japan	Takabe Diabetes Clinic	Himeji	Hyogo
Japan	Nomura Clinic	Itabashi	Tokyo
Japan	Seiryo Internal Medicine	Iwanuma	Miyagi
Japan	Shonan Takai Clinic	Kamakura	Kanagawa
Japan	Takai Internal Medicine Clinic	Kamakura-shi	Kanagawa
Japan	Kashiwa City Hospital	Kashiwa	Chiba
Japan	Shiraiwa Medical Clinic	Kashiwara	Osaka
Japan	Jinnouchi Hospital	Kumamoto
Japan	Yoshimura Clinic	Kumamoto
Japan	Gibo Hepatology Clinic	Matsumoto	Nagano
Japan	Yutenji Medical Clinic	Meguro-ku	Tokyo
Japan	Kanno Naika	Mitaka	Tokyo
Japan	Nakamoto Internal Medicine Clinic	Mito	Ibaraki
Japan	Heiwadai Hospital	Miyazaki
Japan	Ota Diabetes Internal Medicine Clinic	Nagano
Japan	Nakayama Clinic	Nagoya	Aichi
Japan	Tosaki Clinic for Diabetes and Endocrinology	Nagoya-shi	Aichi
Japan	Nakakinen clinic	Naka	Ibaraki
Japan	Nishiyamadou Keiwa Hospital	Naka	Ibaraki
Japan	Kobari General Clinic	Noda	Chiba
Japan	Abe Clinic	Oita
Japan	AMC Nishiumeda Clinic	Osaka
Japan	Kitada Clinic	Osaka
Japan	Nanko Clinic	Osaka
Japan	Osaka Metropolitan Univ Hosp	Osaka
Japan	Yamagishi Clinic Sagamiono	Sagamihara	Kanagawa
Japan	Manda Memorial Hospital	Sapporo	Hokkaido
Japan	Miyanosawa Clinic of Internal Medicine and Cardiology	Sapporo	Hokkaido
Japan	Yuri Ono Clinic	Sapporo	Hokkaido
Japan	Heishinkai Medical Group ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Sugiura Internal Medicine Clinic	Soka	Saitama
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic	Yamato-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 26
Secondary	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.	Baseline, Week 52
Secondary	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.	Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 26
Secondary	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.	Baseline, Week 52