A Phase 4 Study of Dulaglutide When Added to Insulin Treatment in Patients With Type 2 Diabetes

Phase 4

• Conditions: Type 2 Diabetes

• Registration Number: JPRN-jRCT1080223318
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

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 (greater than or equal 7.0%) and (less than or equal 10.5%) at screening if the participant is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or glinides) or (greater than or equal 7.5%) and (less than or equal 10.5%) at screening if the participant is not washing out OADs.
Participants who have stable weight (+-5%) (greater than or equal 3 months) prior to screening.
Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kilogram per square meter).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified