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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02973100 |
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Date of registration:
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22/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
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Scientific title:
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A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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318 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02973100 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Czech Republic
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Czechia
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Mexico
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Poland
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Puerto Rico
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Romania
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United States
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Drug: Placebo
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Drug: Dulaglutide
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Primary Outcome(s)
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Change From Baseline in Hemoglobin A1c (HbA1c)
[Time Frame: Baseline, Week 18]
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Secondary Outcome(s)
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Rate of Documented Symptomatic Hypoglycemia
[Time Frame: Week 18]
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Change From Baseline in Fasting Serum Glucose (FSG)
[Time Frame: Baseline, Week 18]
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Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide
[Time Frame: 0, 2, 4, 6, 10, 18, 22 weeks and early termination]
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Percentage of Participants Discontinuing Study Drug Due to Adverse Events
[Time Frame: Baseline through Week 18]
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Change From Baseline in Body Weight
[Time Frame: Baseline, Week 18]
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Percentage of Participants With HbA1c of <7.0%
[Time Frame: Week 18]
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Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide
[Time Frame: 0, 2, 4, 6, 10, 18, 22 weeks and early termination]
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Secondary ID(s)
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2016-002494-34
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H9X-MC-GBGJ
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16568
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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