A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: Dulaglutide

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic criteria) for at least 1 year.
• Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening).
• Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL) at screening.
• Have a screening body weight of ≥50 and ≤80 kilograms.

Exclusion Criteria:

• Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor agonists.
• Have had a clinically significant cardiovascular disease.
• Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery.
• Have acute or chronic hepatitis, signs and symptoms of any other liver disease.
• Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis.
• Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter squared.
• In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dulaglutide, Placebo; Dulaglutide 0.75 mg administered subcutaneously (SC) once weekly for 4 weeks in period 1 followed by placebo administered SC once weekly for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.	Drug: Placebo; Administered SC; Drug: Dulaglutide; Administered SC; Other Names: LY2189265
Experimental: Placebo, Dulaglutide; Placebo administered SC once weekly for 4 weeks in Period 1 followed by Dulaglutide 0.75 mg administered SC for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.	Drug: Placebo; Administered SC; Drug: Dulaglutide; Administered SC; Other Names: LY2189265

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])	Least square (LS) means of glucose AUC 0-4h change from baseline was calculated using mixed-effects linear model. The model will include treatment, sequence, period, week, and treatment-by-week as fixed effects, baseline as a covariate, and participant as random effect.	Baseline, 4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Blood Glucose	Change from baseline in fasting blood glucose obtained at pre-meal.	Baseline, 4 Weeks
Change From Baseline in Postprandial Blood Glucose	Change from baseline in postprandial blood glucose at 120 minutes at week 4.	Baseline, 4 Weeks
Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])	LS mean of the insulin change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.	Baseline, 4 Weeks
Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])	LS mean of C-peptide change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.	Baseline, 4 Weeks
Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])	LS mean of glucagon change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.	Baseline, 4 Weeks
Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])	LS mean of triglyceride change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.	Baseline, 4 Weeks
Number of Participants Who Develop Hypoglycemic Events	Number of participants who develop hypoglycemic events.	Baseline through 4 weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Inoue M, Shiramoto M, Oura T, Nasu R, Nakano M, Takeuchi M. Effect of Once-Weekly Dulaglutide on Glucose Levels in Japanese Patients with Type 2 Diabetes: Findings from a Phase 4, Randomized Controlled Trial. Diabetes Ther. 2019 Jun;10(3):1019-1027. doi: 10.1007/s13300-019-0605-7. Epub 2019 Apr 4.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: 16730; H9X-JE-GBGK (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes