Diabetes Mellitus, Type 2 Clinical Trial
— AWARD-JPNOfficial 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)
Verified date | April 2024 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Japan,
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 |
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