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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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