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NCT04809220·Phase 3·INTERVENTIONAL

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

DulaglutideType 2 diabetesCompleted

Status

Completed

Phase

Phase 3

Enrollment

591

Locations

44

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Dulaglutide

Administered SC

DRUG

Oral antihyperglycemics

Administered orally

Timeline

From registration to results.

  1. First posted

    Mar 22, 2021

  2. Study start

    Apr 13, 2021

  3. Primary completion

    Oct 1, 2022

  4. Study completion

    Apr 26, 2023

  5. Results posted

    Sep 21, 2023

  6. Registry updated

    May 22, 2024

Outcomes

What the study measures.

Primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26

Time frame · 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 outcomes

Change From Baseline in HbA1c at Week 52

Time frame · 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%

Time frame · 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 Fasting Serum Glucose (FSG)

Time frame · 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 6-point Self-Monitored Blood Glucose (SMBG)

Time frame · 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

Time frame · 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.

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

44 registered sites.

Japan. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsDulaglutide trial dashboard →DatabaseDulaglutide database entry →ResearchDulaglutide research guide →