A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Dulaglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02750410

15803

H9X-JE-GBGF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

159 participants in 2 patient groups, including a placebo group

Dulaglutide

Experimental group

Description:

Dulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks. After 16-weeks, dulaglutide administered once weekly for 36 weeks.

Treatment:

Drug: Dulaglutide

Placebo

Placebo Comparator group

Description:

Placebo administered once weekly for 16 weeks. After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks.

Treatment:

Drug: Placebo

Drug: Dulaglutide