A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03495102
• Date of registration: 02/04/2018
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes AWARD-11
• Scientific title: A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus
• Date of first enrolment: April 5, 2018
• Target sample size: 1842
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03495102
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Canada, Greece, Hungary, Israel, Italy, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, Spain, Taiwan, United States

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have type 2 diabetes mellitus (T2DM) for at least 6 months

- Have been treated with stable metformin dose for at least 3 months

- Have HbA1c =7.5% and =11.0% at study entry

- Have body mass index (BMI) =25 kilograms per meter squared (kg/m^2)

Exclusion Criteria:

- Have type 1 diabetes mellitus

- Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not
including prior short term insulin use (=14 days)

- Have been taking any other medicine for diabetes (other than metformin) during the
last 3 months

- Have used in the last 3 months (or plan to use) prescription weight loss medications

- Have disorders associated with slowed emptying of the stomach contents, or have had
any stomach surgeries for the purpose of weight loss

- Current participation in or intent to begin during the study an organized diet and/or
exercise weight reduction program (other than the lifestyle and dietary measures for
diabetes)

- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (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

- Had chronic or acute pancreatitis any time prior to study entry

- Have had a heart attack or stroke in the past 2 months, or have heart failure that
significantly limits their physical activity

- Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower
than the country-specific threshold for discontinuing metformin therapy per local
label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as
determined by the central laboratory at study entry and confirmed at lead-in

- Have a personal or family history of medullary thyroid carcinoma or personal history
of multiple endocrine neoplasia syndrome type 2

- Have proliferative retinopathy or maculopathy requiring acute treatment according to
the opinion of the investigator



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Dulaglutide

Primary Outcome(s)

Change in Hemoglobin A1c (HbA1c) From Baseline [Time Frame: Baseline, Week 36]

Secondary Outcome(s)

Change in Fasting Serum Glucose (FSG) From Baseline [Time Frame: Baseline, Week 36]

Change in Body Weight From Baseline [Time Frame: Baseline, Week 36]

Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss) [Time Frame: Week 4, Week 12, Week 36, Week 52]

Rate of Documented Symptomatic Hypoglycemic Episodes [Time Frame: Week 36]

Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State [Time Frame: Week 4, Week 12, Week 36, Week 52]

Percentage of Participants Achieving HbA1c Target <7.0% [Time Frame: Week 36]

Secondary ID(s)

16877

2017-003490-33

H9X-MC-GBGL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03495102