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

NCT ID: NCT04809220

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 591 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2023-04-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dulaglutide 1.5 milligram (mg)

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.

Group Type: EXPERIMENTAL

Dulaglutide

Intervention Type: DRUG

Administered SC

Oral antihyperglycemics

Intervention Type: DRUG

Administered orally

Dulaglutide 0.75 mg

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.

Group Type: ACTIVE_COMPARATOR

Dulaglutide

Intervention Type: DRUG

Administered SC

Oral antihyperglycemics

Intervention Type: DRUG

Administered orally

Interventions

Dulaglutide

Administered SC

Intervention Type: DRUG

Oral antihyperglycemics

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY2189265

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Nakayama Clinic

Nagoya, Aichi-ken, Japan

Tosaki Clinic for Diabetes and Endocrinology

Nagoya, Aichi-ken, Japan

Kashiwa City Hospital

Kashiwa, Chiba, Japan

Kobari General Clinic

Noda, Chiba, Japan

Nippon Kokan Fukuyama Hospital

Fukuyama-shi, Hiroshima, Japan

Yamagata Naika Clinic

Asahikawa, Hokkaido, Japan

Hasegawa Medical Clinic

Chitose, Hokkaido, Japan

Yuri Ono Clinic

Sapporo, Hokkaido, Japan

Manda Memorial Hospital

Sapporo, Hokkaido, Japan

Miyanosawa Clinic of Internal Medicine and Cardiology

Sapporo, Hokkaido, Japan

Takabe Diabetes Clinic

Himeji, Hyōgo, Japan

Nakamoto Internal Medicine Clinic

Mito, Ibaraki, Japan

Nakakinen clinic

Naka, Ibaraki, Japan

Nishiyamadou Keiwa Hospital

Naka, Ibaraki, Japan

Hayashi Diabetes Internal Medicine Clinic

Chigasaki, Kanagawa, Japan

Shonan Takai Clinic

Kamakura, Kanagawa, Japan

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, Japan

Yamagishi Clinic Sagamiono

Sagamihara, Kanagawa, Japan

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, Japan

Seiryo Internal Medicine

Iwanuma, Miyagi, Japan

Gibo Hepatology Clinic

Matsumoto, Nagano, Japan

Shiraiwa Medical Clinic

Kashihara, Osaka, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, Japan

Sugiura Internal Medicine Clinic

Sōka, Saitama, Japan

Seiwa Clinic

Adachi-ku, Tokyo, Japan

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, Japan

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Hachioji Diabetes Clinic

Hachiōji, Tokyo, Japan

Minamino Cardiovascular Hospital

Hachiōji, Tokyo, Japan

Yutenji Medical Clinic

Meguro-ku, Tokyo, Japan

Kanno Naika

Mitaka, Tokyo, Japan

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Tokyo, Japan

Nomura Clinic

tabashi City, Tokyo, Japan

Futata Tetsuhiro Clinic

Fukuoka, , Japan

Yoshimura Clinic

Kumamoto, , Japan

Jinnouchi Hospital

Kumamoto, , Japan

Heiwadai Hospital

Miyazaki, , Japan

Ota Diabetes Internal Medicine Clinic

Nagano, , Japan

AMC Nishiumeda Clinic

Osaka, , Japan

Kitada Clinic

Osaka, , Japan

Osaka Metropolitan Univ Hosp

Osaka, , Japan

Nanko Clinic

Osaka, , Japan

Abe Clinic

Ōita, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H9X-JE-GBGQ

Identifier Type: OTHER

Identifier Source: secondary_id

17779

Identifier Type: -

Identifier Source: org_study_id