A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication in Patients With Type 2 Diabetes

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.

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