Phase 2
Completed N=318
A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
Source: ClinicalTrials.gov NCT02973100 ↗Enrolled (actual)
318
Serious AEs
5.4%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — -0.44; -1.23; -1.31; -1.40 Percentage of glycosylated hemoglobin — p=<.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.44; -1.23; -1.31; -1.40 | <.001 sig |
| SECONDARY Percentage of Participants With HbA1c of <7.0% |
20; 71.2; 71.2; 68.2 | <.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose (FSG) |
-0.69; -2.01; -1.92; -2.11 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-1.6; -2.8; -3.9; -4.1 | 0.025 sig |
| SECONDARY Percentage of Participants Discontinuing Study Drug Due to Adverse Events |
4.9; 6.2; 10.1; 13.2 | — |
| SECONDARY Rate of Documented Symptomatic Hypoglycemia |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide |
90.4; 151; 204 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide |
11800; 26700; 36600 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02973100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.