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

Lilly

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03315780

H9X-JE-GBGK (Other Identifier)

16730

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Dulaglutide, Placebo

Experimental group

Description:

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.

Treatment:

Drug: Dulaglutide

Drug: Placebo

Placebo, Dulaglutide

Experimental group

Description:

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.

Treatment:

Drug: Dulaglutide

Drug: Placebo