A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Dulaglutide

• 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

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-25
• Study Start: 2016-12
• Primary Completion: 2017-07-15
• Study Completion: 2017-08-14
• Results First Submitted: 2018-07-13
• Results First Submitted QC: 2018-08-22
• Results First Posted: 2018-08-24
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

• 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

Exclusion Criteria

• 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

National Research Institute; 🇺🇸 Los Angeles, California, United States

Catalina Research Institute, LLC; 🇺🇸 Montclair, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Encompass Clinical Research; 🇺🇸 Spring Valley Lake, 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

Chase Medical Research, LLC; 🇺🇸 Waterbury, Connecticut, United States

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