Clinical trial NCT04809220: A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Disease
Endocrine System Diseases
Hypoglycemic Agents
Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 591
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%
timeFrame: Week 52
measure: Change From Baseline in Fasting Serum Glucose (FSG)
timeFrame: Baseline, Week 52
measure: Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)
timeFrame: Baseline, Week 26
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Tosaki Clinic for Diabetes and Endocrinology
state: Aichi
city: Nagoya
country: Japan
facility: Nakayama Clinic
state: Aichi
city: Kashiwa
country: Japan
facility: Kashiwa City Hospital
state: Chiba
city: Noda
country: Japan
facility: Kobari General Clinic
state: Chiba
city: Fukuyama-shi
country: Japan
facility: Nippon Kokan Fukuyama Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: Yamagata Naika Clinic
state: Hokkaido
city: Chitose
country: Japan
facility: Hasegawa Medical Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Yuri Ono Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Manda Memorial Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Miyanosawa Clinic of Internal Medicine and Cardiology
state: Hokkaido
city: Himeji
country: Japan
facility: Takabe Diabetes Clinic
state: Hyogo
city: Mito
country: Japan
facility: Nakamoto Internal Medicine Clinic
state: Ibaraki
city: Naka
country: Japan
facility: Nakakinen clinic
state: Ibaraki
city: Naka
country: Japan
facility: Nishiyamadou Keiwa Hospital
state: Ibaraki
city: Chigasaki
country: Japan
facility: Hayashi Diabetes Internal Medicine Clinic
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Takai Clinic
state: Kanagawa
city: Sagamihara
country: Japan
facility: Yamagishi Clinic Sagamiono
state: Kanagawa
city: Yamato-shi
country: Japan
facility: Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Iwanuma
country: Japan
facility: Seiryo Internal Medicine
state: Miyagi
city: Matsumoto
country: Japan
facility: Gibo Hepatology Clinic
state: Nagano
city: Kashiwara
country: Japan
facility: Shiraiwa Medical Clinic
state: Osaka
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Soka
country: Japan
facility: Sugiura Internal Medicine Clinic
state: Saitama
city: Adachi-ku
country: Japan
facility: Seiwa Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Medical Corporation Chiseikai Tokyo Center Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Hachioji
country: Japan
facility: Hachioji Diabetes Clinic
state: Tokyo
city: Hachioji
country: Japan
facility: Minamino Cardiovascular Hospital
state: Tokyo
city: Itabashi
country: Japan
facility: Nomura Clinic
state: Tokyo
city: Meguro-ku
country: Japan
facility: Yutenji Medical Clinic
state: Tokyo
city: Mitaka
country: Japan
facility: Kanno Naika
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Futata Tetsuhiro Clinic
city: Kumamoto
country: Japan
facility: Yoshimura Clinic
city: Kumamoto
country: Japan
facility: Jinnouchi Hospital
city: Miyazaki
country: Japan
facility: Heiwadai Hospital
city: Nagano
country: Japan
facility: Ota Diabetes Internal Medicine Clinic
city: Oita
country: Japan
facility: Abe Clinic
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Osaka
country: Japan
facility: Kitada Clinic
city: Osaka
country: Japan
facility: Osaka Metropolitan Univ Hosp
city: Osaka
country: Japan
facility: Nanko Clinic
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: