Phase 4
Completed N=12
A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03315780 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h]) — -238.46; 15.56 milligram*hour per deciliter (mg*h/dL) — p=< 0.0001
◆ Published Evidence
Emerging
11citations · ~2 / year
Effect of Once-Weekly Dulaglutide on Glucose Levels in Japanese Patients with Type 2 Diabetes: Findings from a Phase 4, Randomized Controlled Trial.
Summary
The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.
Linked Publications
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Effect of Once-Weekly Dulaglutide on Glucose Levels in Japanese Patients with Type 2 Diabetes: Findings from a Phase 4, Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h]) |
-238.46; 15.56 | < 0.0001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-39.8; -8.2 | — |
| SECONDARY Change From Baseline in Postprandial Blood Glucose |
-67.0; 13.9 | — |
| SECONDARY Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) |
25.20; -2.27 | 0.0100 sig |
| SECONDARY Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) |
3.58; -0.14 | 0.0263 sig |
| SECONDARY Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) |
-16.39; -7.02 | 0.0800 |
| SECONDARY Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) |
31.02; 46.41 | 0.7475 |
| SECONDARY Number of Participants Who Develop Hypoglycemic Events |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03315780) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.