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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315780
• Other study ID #: 16730
• Secondary ID: H9X-JE-GBGK
• Status: Completed
• Phase: Phase 4
• Start date: October 28, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: August 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dulaglutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Fasting Blood Glucose	Change from baseline in fasting blood glucose obtained at pre-meal.	Baseline, 4 Weeks
Secondary	Change From Baseline in Postprandial Blood Glucose	Change from baseline in postprandial blood glucose at 120 minutes at week 4.	Baseline, 4 Weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants Who Develop Hypoglycemic Events	Number of participants who develop hypoglycemic events.	Baseline through 4 weeks