A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus

Part of paid clinical trials in Encino, California.

Sponsor
Eli Lilly and Company
Study ID
NCT02597049
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC
  • SGLT2 inhibitor — DRUG
    Administered orally as standard of care for type 2 diabetes
  • Metformin — DRUG
    Administered orally as standard of care for type 2 diabetes

Study Details

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.

Key Dates

Start date
Nov 30, 2015
Status verified
Jun 2020
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
424 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1.5 mg Dulaglutide
    1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.
  • Experimental: 0.75 mg Dulaglutide
    0.75 mg dulaglutide given SC once a week for 24 weeks.
  • Placebo Comparator: Placebo
    Placebo given SC once a week for 24 weeks.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand) [ Time Frame: Baseline, Week 24 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Medical Group of EncinoEncinoCalifornia91436-
National Research InstituteHuntington ParkCalifornia90255-
National Research InstituteLos AngelesCalifornia90057-
New Horizon Research CenterMiamiFlorida33175-
Metabolic Research Institute Inc.West Palm BeachFlorida33401-
Cotton O'Neil Diabetes and Endocrinology CenterTopekaKansas66606-
JCMG Clinical ResearchJefferson CityMissouri65109-
Grand Street Medical PCBrooklynNew York11211-
Diabetes & Endocrinology Consultants PCMorehead CityNorth Carolina28557-
PMG Research of Wilmington, LLCWilmingtonNorth Carolina28401-
Dallas Diabetes Endocrine CenterDallasTexas75230-
Galenos ResearchDallasTexas75251-
Endeavor Clinical TrialsSan AntonioTexas78229-

Find similar trials in Encino, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Medical Group of Encino· Encino, CANational Research Institute· Huntington Park, CANational Research Institute· Los Angeles, CANew Horizon Research Center· Miami, FLMetabolic Research Institute Inc.· West Palm Beach, FLCotton O'Neil Diabetes and Endocrinology Center· Topeka, KS

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