Phase 3 N=591 Randomized Double-blind Treatment

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

Diabetes Mellitus · Diabetes Mellitus, Type 2 · Glucose Metabolism Disorders · Metabolic Disease · Endocrine System Diseases

Bottom Line

View on ClinicalTrials.gov: NCT04809220 ↗

Enrolled (actual)

591

Serious AEs

3.8%

Results posted

Sep 2023

Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 — -1.53; -1.25 Percentage of HbA1c — p=<.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dulaglutide (Drug); Oral antihyperglycemics (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26	-1.53; -1.25	<.001 sig
SECONDARY Change From Baseline in HbA1c at Week 52	-1.50; -1.19	<.001 sig
SECONDARY Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%	22.88; 21.26; 46.33; 38.51	0.560
SECONDARY Change From Baseline in Fasting Serum Glucose (FSG)	-42.4; -33.1	<.001 sig
SECONDARY Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)	-45.6; -38.4; -70.6; -60.5; -55.3; -47.0	0.002 sig
SECONDARY Change From Baseline in Body Weight	-0.5; -0.2	0.213

Summary

The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.

Eligibility Criteria

Inclusion Criteria

Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.
Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.
Have the following HbA1c result at screening.
Participants taking DPP-4i: ≥7.5% and ≤9.5%,
Participants taking another OAM: ≥8.0% and ≤10.0%
Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks
Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and <35 kg/m² at Day 1.

Exclusion Criteria

Have type 1 diabetes (T1D)
Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
Have a known clinically significant gastric empty abnormality
Have acute or chronic hepatitis
Have had chronic or acute pancreatitis
Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)
Have evidence of significant, active autoimmune abnormality
Have evidence of significant, uncontrolled endocrine abnormality
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
Have any hematologic condition that may interfere with HbA1c measurement

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04809220). 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.