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

Lilly

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02973100

16568

H9X-MC-GBGJ (Other Identifier)

2016-002494-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 318 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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318 participants in 4 patient groups, including a placebo group

Dulaglutide 4.5mg

Experimental group

Description:

4.5mg of Dulaglutide administered subcutaneously (SC)

Treatment:

Drug: Dulaglutide

Dulaglutide 3.0mg

Experimental group

Description:

3.0mg of Dulaglutide administered SC

Treatment:

Drug: Dulaglutide

Dulaglutide 1.5mg

Active Comparator group

Description:

1.5mg of Dulaglutide administered SC

Treatment:

Drug: Dulaglutide

Placebo

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo