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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dulaglutide; Drug: Placebo

• Registration Number: NCT03315780
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Study Start: 2017-10-28
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Results First Submitted: 2019-02-25
• Results First Submitted QC: 2019-04-09
• Results First Posted: 2019-04-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dulaglutide, Placebo	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.
Placebo, Dulaglutide	Placebo	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.
Dulaglutide, Placebo	Dulaglutide	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.
Placebo, Dulaglutide	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])	Baseline, 4 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Blood Glucose	Baseline, 4 Weeks	Change from baseline in fasting blood glucose obtained at pre-meal.
Change From Baseline in Postprandial Blood Glucose	Baseline, 4 Weeks	Change from baseline in postprandial blood glucose at 120 minutes at week 4.
Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])	Baseline, 4 Weeks	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.
Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])	Baseline, 4 Weeks	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.
Number of Participants Who Develop Hypoglycemic Events	Baseline through 4 weeks	Number of participants who develop hypoglycemic events.
Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])	Baseline, 4 Weeks	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.
Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])	Baseline, 4 Weeks	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.

Trial Locations

Locations (1)

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.; 🇯🇵 Fukuoka, Japan