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

Phase 3

Completed

• Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; Endocrine System Diseases; Metabolic Disease; Type 2 Diabetes Mellitus (T2DM); Glucose Metabolism Disorders; Hypoglycemic Agents
• Interventions: Drug: Dulaglutide; Drug: Oral antihyperglycemics

• Registration Number: NCT04809220
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Study Start: 2021-04-13
• Primary Completion: 2022-10-01
• Study Completion: 2023-04-26
• Results First Submitted: 2023-08-24
• Results First Submitted QC: 2023-08-24
• Results First Posted: 2023-09-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dulaglutide 1.5 milligram (mg)	Oral antihyperglycemics	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.
Dulaglutide 0.75 mg	Oral antihyperglycemics	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.
Dulaglutide 0.75 mg	Dulaglutide	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.
Dulaglutide 1.5 milligram (mg)	Dulaglutide	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Serum Glucose (FSG)	Baseline, Week 52	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.
Change From Baseline in HbA1c at Week 52	Baseline, 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.
Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%	Week 52	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.
Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)	Baseline, Week 26	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.
Change From Baseline in Body Weight	Baseline, Week 52	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.

Trial Locations

Locations (44)

Ota Diabetes Internal Medicine Clinic; 🇯🇵 Nagano, Japan

Heiwadai Hospital; 🇯🇵 Miyazaki, Japan

Hachioji Diabetes Clinic; 🇯🇵 Hachioji, Tokyo, Japan

Tosaki Clinic for Diabetes and Endocrinology; 🇯🇵 Nagoya-shi, Aichi, Japan

Nakayama Clinic; 🇯🇵 Nagoya, Aichi, Japan

Nippon Kokan Fukuyama Hospital; 🇯🇵 Fukuyama-shi, Hiroshima, Japan

Kobari General Clinic; 🇯🇵 Noda, Chiba, 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, Hyogo, 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

Takai Internal Medicine Clinic; 🇯🇵 Kamakura-shi, Kanagawa, Japan

Seiryo Internal Medicine; 🇯🇵 Iwanuma, Miyagi, Japan

Gibo Hepatology Clinic; 🇯🇵 Matsumoto, Nagano, Japan

Medical Corporation Heishinkai OCROM Clinic; 🇯🇵 Suita-shi, Osaka, Japan

Sugiura Internal Medicine Clinic; 🇯🇵 Soka, Saitama, Japan

Seiwa Clinic; 🇯🇵 Adachi-ku, Tokyo, Japan

Tokyo-Eki Center-building Clinic; 🇯🇵 Chuo-ku, Tokyo, Japan

Fukuwa Clinic; 🇯🇵 Chuo-ku, Tokyo, Japan

Nomura Clinic; 🇯🇵 Itabashi, Tokyo, Japan

Yutenji Medical Clinic; 🇯🇵 Meguro-ku, Tokyo, Japan

Kanno Naika; 🇯🇵 Mitaka, Tokyo, Japan

Futata Tetsuhiro Clinic; 🇯🇵 Fukuoka, Japan

Yoshimura Clinic; 🇯🇵 Kumamoto, Japan

Jinnouchi Hospital; 🇯🇵 Kumamoto, Japan

Shonan Takai Clinic; 🇯🇵 Kamakura, Kanagawa, Japan

Yamagishi Clinic Sagamiono; 🇯🇵 Sagamihara, Kanagawa, Japan

AMC Nishiumeda Clinic; 🇯🇵 Osaka, Japan

Kashiwa City Hospital; 🇯🇵 Kashiwa, Chiba, Japan

Nanko Clinic; 🇯🇵 Osaka, Japan

Medical Corporation Chiseikai Tokyo Center Clinic; 🇯🇵 Chuo-ku, Tokyo, Japan

Heishinkai Medical Group ToCROM Clinic; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Yamagata Naika Clinic; 🇯🇵 Asahikawa, Hokkaido, Japan

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic; 🇯🇵 Yamato-shi, Kanagawa, Japan

Shiraiwa Medical Clinic; 🇯🇵 Kashiwara, Osaka, Japan

Minamino Cardiovascular Hospital; 🇯🇵 Hachioji, Tokyo, Japan

Abe Clinic; 🇯🇵 Oita, Japan

Kitada Clinic; 🇯🇵 Osaka, Japan

Osaka Metropolitan Univ Hosp; 🇯🇵 Osaka, Japan