A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus

Eli Lilly and Company206 sites in 1 country1,842 target enrollmentApril 5, 2018

ConditionsDiabetes Mellitus, Type 2

InterventionsDulaglutide

DrugsDulaglutide

Overview

Phase: Phase 3
Intervention: Dulaglutide
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Enrollment: 1842
Locations: 206
Primary Endpoint: Change in Hemoglobin A1c (HbA1c) From Baseline
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.

Registry

clinicaltrials.gov

Start Date

April 5, 2018

End Date

October 10, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have type 2 diabetes mellitus (T2DM) for at least 6 months
•Have been treated with stable metformin dose for at least 3 months
•Have HbA1c ≥7.5% and ≤11.0% at study entry
•Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m\^2)

Exclusion Criteria

•Have type 1 diabetes mellitus
•Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)
•Have been taking any other medicine for diabetes (other than metformin) during the last 3 months
•Have used in the last 3 months (or plan to use) prescription weight loss medications
•Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss
•Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)
•Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
•Had chronic or acute pancreatitis any time prior to study entry
•Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity
•Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73m\^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in

Arms & Interventions

Dulaglutide 1.5 mg

Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.

Intervention: Dulaglutide

Dulaglutide 3 mg

Dulaglutide 3 mg administered SC once a week.

Intervention: Dulaglutide

Dulaglutide 4.5 mg

Dulaglutide 4.5 mg administered SC once a week.

Intervention: Dulaglutide

Outcomes

Primary Outcomes

Change in Hemoglobin A1c (HbA1c) From Baseline

Time Frame: Baseline, Week 36

HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).

Secondary Outcomes

Percentage of Participants Achieving HbA1c Target <7.0%(Week 36)
Rate of Documented Symptomatic Hypoglycemic Episodes(Week 36)
Change in Fasting Serum Glucose (FSG) From Baseline(Baseline, Week 36)
Change in Body Weight From Baseline(Baseline, Week 36)
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)(Week 4, Week 12, Week 36, Week 52)
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State(Week 4, Week 12, Week 36, Week 52)