A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Dulaglutide

Registration Number: NCT03495102

Lead Sponsor: Eli Lilly and Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1842

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
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dulaglutide 4.5 mg	Dulaglutide	Dulaglutide 4.5 mg administered SC once a week.
Dulaglutide 3 mg	Dulaglutide	Dulaglutide 3 mg administered SC once a week.
Dulaglutide 1.5 mg	Dulaglutide	Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c (HbA1c) From Baseline	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 Outcome Measures

Name	Time	Method
Percentage of Participants Achieving HbA1c Target <7.0%	Week 36	Percentage of participants achieving HbA1c target \<7.0%.
Rate of Documented Symptomatic Hypoglycemic Episodes	Week 36	Hypoglycemia was defined as blood glucose \< 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Change in Fasting Serum Glucose (FSG) From Baseline	Baseline, Week 36	Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change in Body Weight From Baseline	Baseline, Week 36	Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)	Week 4, Week 12, Week 36, Week 52	Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State	Week 4, Week 12, Week 36, Week 52	Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.

Trial Locations

Locations (206): Synexus- Chandler
🇺🇸
Chandler, Arizona, United States
Synexus/Central Arizona Medical Associates, PC
🇺🇸
Mesa, Arizona, United States
Central Phoenix Med Clinic LLC
🇺🇸
Phoenix, Arizona, United States
Arkansas Clinical Research
🇺🇸
Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
🇺🇸
Anaheim, California, United States
Valley Research
🇺🇸
Fresno, California, United States
National Research Institute
🇺🇸
Panorama City, California, United States
Catalina Research Institute, LLC
🇺🇸
Montclair, California, United States
Valley Clinical Trials, Inc.
🇺🇸
Northridge, California, United States
Pacific Research Partners, LLC
🇺🇸
Oakland, California, United States
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Synexus- Chandler
🇺🇸Chandler, Arizona, United States