Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments dulaglutide, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date November 2015
End date February 2017
Trial size 426 participants
Trial identifier NCT02597049, 15361, 2015-002095-24, H9X-MC-GBGE

Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in participants with type 2 diabetes mellitus.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
.75 milligrams (mg) dulaglutide given subcutaneously (SC) once a week for 24 weeks.
dulaglutide LY2189265
Administered SC
(Experimental)
1.5 mg dulaglutide given SC once a week for 24 weeks.
dulaglutide LY2189265
Administered SC
(Placebo Comparator)
Placebo given SC once a week for 24 weeks.
placebo
Administered SC

Primary Outcomes

Measure
Change from Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks
time frame: Baseline, 24 Weeks

Secondary Outcomes

Measure
Proportion of Participants with HbA1c <7%
time frame: 24 Weeks
Change from Baseline in Fasting Blood Glucose (central laboratory) at 24 Weeks
time frame: Baseline, 24 Weeks
Change from Baseline in Body Weight at 24 Weeks
time frame: Baseline, 24 Weeks
Change from Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks
time frame: Baseline, 24 Weeks
Change from Baseline in Fasting Glucagon at 24 Weeks
time frame: Baseline, 24 Weeks
Rate of Hypoglycemic Events Adjusted Per 30 Days
time frame: Baseline through 24 Weeks
Number of Participants With Adjudicated Cardiovascular Events
time frame: Baseline through 24 Weeks
Number of Participants With Adjudicated Acute Pancreatitis Events
time frame: Baseline through 24 Weeks
Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia
time frame: Baseline through 24 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Have type 2 diabetes mellitus (based on the World Health Organization's [WHO] diagnostic criteria) - Have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry (minimum required doses for that period for allowed SGLT2 inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg [per country-specific label], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500 mg/day and must be reached (or highest tolerated dose which is acceptable with documented gastrointestinal [GI] intolerability) - Daily doses of all allowed oral antihyperglycemia agent (OAMs) must have been stable for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses of SGLT2 inhibitor and metformin, if used, will be considered stable during this period if: - all prescribed daily doses were in the range between the minimum required dose and maximum-approved dose per country-specific label; and - >90% of prescribed daily doses were equal to the dose at randomization - Have HbA1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to randomization - Have body mass index (BMI) ≤45 kilograms per meter squared (kg/m^2) and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment Exclusion Criteria: - Have type 1 diabetes mellitus - Have been treated with ANY other OAMs (other than SGLT2 inhibitors and metformin), glucagon-like peptide-1 receptor agonist (GLP-1 RA), pramlintide or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary - Have any condition that is a contraindication for use of the GLP-1 RA class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization - 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 - Estimated glomerular filtration rate (eGFR) <45 milliliters(mL)/minute/1.73m^2, 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 any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes participants with a family history of MEN 2A or 2B, whose family history for the syndrome is rearranged during transfect [RET]- negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for the RET mutation) - Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome) - Have a serum calcitonin ≥20 picograms/mL as determined by the central laboratory at study entry

Additional Information

Official title A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.