A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

Lilly logo

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

Trial documents
2

Trial contacts and locations

25

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems