Phase 4
Completed N=159
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02750410 ↗Enrolled (actual)
159
Serious AEs
3.1%
Results posted
Sep 2019
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — 0.06; -1.45 percentage of HbA1c — p=<0.001
◆ Published Evidence
Emerging
10citations · ~2 / year
Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study.
Summary
The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.
Linked Publications (2)
-
Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study.
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Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
0.06; -1.45 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c <7.0% or ≤6.5% |
47.4; 0 | 0.003 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose (FSG) |
-4.1; -34.2 | <0.001 sig |
| SECONDARY Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG) |
12.30; -14.28; 13.15; -32.24; 8.08; -28.74 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-0.30; -0.20 | 0.776 |
| SECONDARY Change From Baseline in Daily Total Insulin Dose |
-0.3; -1.1 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who have had a diagnosis of type 2 diabetes mellitus
- Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening
- Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs
- Participants who have stable weight (±5%) ≥3 months prior to screening
- Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m^2)
Exclusion Criteria
- Participants who have a diagnosis of type 1 diabetes
- Participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening
- Participants who have been previously treated with dulaglutide prior to screening
- Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide)
- Participants who have been treated with continuous subcutaneous insulin infusion (CSII) at screening
- Participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities
- Participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy
Data sourced from ClinicalTrials.gov (NCT02750410) 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.