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

Part of paid clinical trials in Fresno, California.

Sponsor
Eli Lilly and Company
Study ID
NCT02152371
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dulaglutide — DRUG
    Administered SQ
  • Placebo — DRUG
    Administered SQ
  • Insulin Glargine — DRUG
    Administered SQ
  • Metformin — DRUG
    Administered orally

Study Details

The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine. The study will last about 31 weeks for each participant.

Key Dates

Start date
May 31, 2014
Status verified
Sep 2019
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

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

Arms

  • Experimental: Dulaglutide + Insulin Glargine
    1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
  • Placebo Comparator: Placebo + Insulin Glargine
    Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.

Primary Outcome Measure

Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 28 Weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Valley Endocrine, FresnoFresnoCalifornia93720-
Mills-Peninsula Diabetes Research InsituteSan MateoCalifornia94401-
University Clinical Investigators, Inc.TustinCalifornia92780-
Rocky Mountain Diabetes and Osteoporosis CenterIdaho FallsIdaho83404-
Northwest Endo Diabetes Research, LLCArlington HeightsIllinois60005-
Cotton O'Neil ClinicTopekaKansas66606-
Kentucky Diabetes Endocrinology CenterLexingtonKentucky40503-
AB Clinical TrialsLas VegasNevada89119-
SHS Clinical Research GroupToms RiverNew Jersey08753-
Bland Clinic, PAGreensboroNorth Carolina27401-
PMG Research of KnoxvilleKnoxvilleTennessee37912-
Rainier Clinical Research CenterRentonWashington98057-
PolyclinicSeattleWashington98104-

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