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

NCT04809220 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 17779H9X-JE-GBGQ
• Study Type: interventional
• Target: 591
• Locations: 1 country
• Sites: 44

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change From Baseline in HbA1c at Week 52

  Baseline, Week 52

• Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%

  Week 52

• Change From Baseline in Fasting Serum Glucose (FSG)

  Baseline, Week 52

• Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)

  Baseline, Week 26

• Change From Baseline in Body Weight

  Baseline, Week 52

Study Arms (2)

Dulaglutide 1.5 milligram (mg)

EXPERIMENTAL

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.

Drug: Dulaglutide; Drug: Oral antihyperglycemics

Dulaglutide 0.75 mg

ACTIVE COMPARATOR

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.

Drug: Dulaglutide; Drug: Oral antihyperglycemics

Interventions

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

Dulaglutide 0.75 mg; Dulaglutide 1.5 milligram (mg)

Oral antihyperglycemics DRUG

Administered orally

Dulaglutide 0.75 mg; Dulaglutide 1.5 milligram (mg)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (44)

Nakayama Clinic

Nagoya, Aichi-ken, 456-0058, Japan

Location

Tosaki Clinic for Diabetes and Endocrinology

Nagoya, Aichi-ken, 468-0009, Japan

Location

Kashiwa City Hospital

Kashiwa, Chiba, 277-0825, Japan

Location

Kobari General Clinic

Noda, Chiba, 278-0004, Japan

Location

Nippon Kokan Fukuyama Hospital

Fukuyama-shi, Hiroshima, 721-0927, Japan

Location

Yamagata Naika Clinic

Asahikawa, Hokkaido, 078-8234, Japan

Location

Hasegawa Medical Clinic

Chitose, Hokkaido, 066-0032, Japan

Location

Yuri Ono Clinic

Sapporo, Hokkaido, 060-0001, Japan

Location

Manda Memorial Hospital

Sapporo, Hokkaido, 060-0062, Japan

Location

Miyanosawa Clinic of Internal Medicine and Cardiology

Sapporo, Hokkaido, 063-0826, Japan

Location

Takabe Diabetes Clinic

Himeji, Hyōgo, 670-0837, Japan

Location

Nakamoto Internal Medicine Clinic

Mito, Ibaraki, 310-0826, Japan

Location

Nakakinen clinic

Naka, Ibaraki, 311-0113, Japan

Location

Nishiyamadou Keiwa Hospital

Naka, Ibaraki, 311-0133, Japan

Location

Hayashi Diabetes Internal Medicine Clinic

Chigasaki, Kanagawa, 253-0044, Japan

Location

Shonan Takai Clinic

Kamakura, Kanagawa, 247-0055, Japan

Location

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, 247-0056, Japan

Location

Yamagishi Clinic Sagamiono

Sagamihara, Kanagawa, 252-0303, Japan

Location

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, 242-0004, Japan

Location

Seiryo Internal Medicine

Iwanuma, Miyagi, 989-2451, Japan

Location

Gibo Hepatology Clinic

Matsumoto, Nagano, 399-0036, Japan

Location

Shiraiwa Medical Clinic

Kashihara, Osaka, 582-0005, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

Sugiura Internal Medicine Clinic

Sōka, Saitama, 340-0034, Japan

Location

Seiwa Clinic

Adachi-ku, Tokyo, 120-0011, Japan

Location

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, 103-0028, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Hachioji Diabetes Clinic

Hachiōji, Tokyo, 192-0083, Japan

Location

Minamino Cardiovascular Hospital

Hachiōji, Tokyo, 192-0918, Japan

Location

Yutenji Medical Clinic

Meguro-ku, Tokyo, 153-0053, Japan

Location

Kanno Naika

Mitaka, Tokyo, 181-0013, Japan

Location

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Nomura Clinic

tabashi City, Tokyo, 173-0004, Japan

Location

Futata Tetsuhiro Clinic

Fukuoka, 810-0006, Japan

Location

Yoshimura Clinic

Kumamoto, 861-8039, Japan

Location

Jinnouchi Hospital

Kumamoto, 862-0976, Japan

Location

Heiwadai Hospital

Miyazaki, 880-0034, Japan

Location

Ota Diabetes Internal Medicine Clinic

Nagano, 380-0802, Japan

Location

AMC Nishiumeda Clinic

Osaka, 530-0001, Japan

Location

Kitada Clinic

Osaka, 538-0044, Japan

Location

Osaka Metropolitan Univ Hosp

Osaka, 545-8586, Japan

Location

Nanko Clinic

Osaka, 559-0011, Japan

Location

Abe Clinic

Ōita, 870-0039, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Interventions

dulaglutide; Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 22, 2021
• Study Start: April 13, 2021
• Primary Completion: October 1, 2022
• Study Completion: April 26, 2023
• Last Updated: May 22, 2024
• Results First Posted: September 21, 2023

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (44)