A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
- Registration Number
- NCT02973100
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
- Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
- Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
- Have been treated with stable doses of metformin for at least 3 months
- Have a body mass index (BMI) ≥25 kilograms per square meter
- Have type 1 diabetes (T1D)
- Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
- Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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
- Have had chronic or acute pancreatitis any time prior to study entry
- Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation
- Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered SC Dulaglutide 4.5mg Dulaglutide 4.5mg of Dulaglutide administered subcutaneously (SC) Dulaglutide 3.0mg Dulaglutide 3.0mg of Dulaglutide administered SC Dulaglutide 1.5mg Dulaglutide 1.5mg of Dulaglutide administered SC
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 18 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment\*time as fixed effects.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Discontinuing Study Drug Due to Adverse Events Baseline through Week 18 Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.
Change From Baseline in Fasting Serum Glucose (FSG) Baseline, Week 18 Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using \>=8% as cutoff, treatment, time, treatment\*time as fixed effects.
Change From Baseline in Body Weight Baseline, Week 18 Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using \>=8% as cutoff, treatment, time, treatment\*time as fixed effects.
Rate of Documented Symptomatic Hypoglycemia Week 18 Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.
Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide 0, 2, 4, 6, 10, 18, 22 weeks and early termination Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.
Percentage of Participants With HbA1c of <7.0% Week 18 Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide 0, 2, 4, 6, 10, 18, 22 weeks and early termination AUC\[0-168h\] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.
Trial Locations
- Locations (40)
Parexel Early Phase Unit at Glendale
🇺🇸Glendale, California, United States
Marin Endocrine Associates
🇺🇸Greenbrae, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Encompass Clinical Research
🇺🇸Spring Valley Lake, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Infosphere
🇺🇸Van Nuys, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Suncoast Research Group, LLC
🇺🇸Miami Lakes, Florida, United States
In-Quest Medical Research, LLC - Norcross
🇺🇸Norcross, Georgia, United States
East Coast Institute For Research
🇺🇸Jacksonville, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
American Health Network
🇺🇸Indianapolis, Indiana, United States
HSHS Medical Group Diabetes Research
🇺🇸Springfield, Illinois, United States
Iderc, P.L.C.
🇺🇸Des Moines, Iowa, United States
ActivMed Practices & Research, Inc
🇺🇸Methuen, Massachusetts, United States
StudyMetrix Research, LLC
🇺🇸Saint Peters, Missouri, United States
Manhattan Medical Research
🇺🇸New York Mills, New York, United States
High Point Clinical Trials Center
🇺🇸High Point, North Carolina, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
The Corvallis Clinic P.C.
🇺🇸Corvallis, Oregon, United States
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Dallas Diabetes Endocrine Center
🇺🇸Dallas, Texas, United States
Consano Clinical Research
🇺🇸San Antonio, Texas, United States
Clinpoint Trial, LLC
🇺🇸Waxahachie, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Marginal Doctor's Center
🇵🇷Manati, Puerto Rico
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
American Telemedicine Center
🇵🇷San Juan, Puerto Rico
Elite Cilnical Trials LLLP
🇺🇸Blackfoot, Idaho, United States
New Phase Research & Development
🇺🇸Knoxville, Tennessee, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇷🇴Satu-Mare, Romania
East West Medical Institute
🇺🇸Honolulu, Hawaii, United States
Cotton O'Neil Diabetes and Endocrinology Center
🇺🇸Topeka, Kansas, United States
Axes Medical Research, LLC
🇺🇸Cooper City, Florida, United States