Clinical trial NCT03315780: A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes
Official title: A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])
timeFrame: Baseline, 4 Weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline, 4 Weeks
measure: Change From Baseline in Postprandial Blood Glucose
timeFrame: Baseline, 4 Weeks
measure: Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])
timeFrame: Baseline, 4 Weeks
measure: Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])
timeFrame: Baseline, 4 Weeks
measure: Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])
timeFrame: Baseline, 4 Weeks
measure: Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])
timeFrame: Baseline, 4 Weeks
measure: Number of Participants Who Develop Hypoglycemic Events
timeFrame: Baseline through 4 weeks
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: 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.