A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)

Part of paid clinical trials in Montgomery, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT01621178
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dulaglutide — DRUG
    Administered SC
  • Insulin glargine — DRUG
    Administered SC
  • Insulin lispro — DRUG
    Administered SC

Study Details

The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease.

Key Dates

Start date
Jul 31, 2012
Status verified
Sep 2019
Primary completion
Jun 30, 2016
Completion
Dec 31, 2016

Study Design

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

Arms

  • Active Comparator: Insulin glargine
    Insulin glargine was administered subcutaneously (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
  • Experimental: 0.75 mg Dulaglutide
    0.75 milligram (mg) of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
  • Experimental: 1.5 mg Dulaglutide
    1.5 mg of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 26 Weeks ]

Locations (47)

FacilityCityStateZIPSite coordinators
Extended Arm Physician, Inc.MontgomeryAlabama36106-
North American Research InstituteAzusaCalifornia91702-
Renal Consultants Medical GroupGranada HillsCalifornia91344-
Marin Endocrine AssociatesGreenbraeCalifornia94904-
Academic Medical Research InstituteLos AngelesCalifornia90022-
Sutter Gould Medical FoundationModestoCalifornia95355-
InfosphereWest HillsCalifornia91307-
Chase Medical Research, LLCWaterburyConnecticut06708-
The Center for Diabetes & Endocrine CareHollywoodFlorida33312-
East Coast Clinical ResearchJacksonvilleFlorida32204-
Avanced Medical and Pain Mangement Research Clinic (AMPM)MiamiFlorida33145-
Baptist Diabetes AssociationMiamiFlorida33156-
Pharmax Research ClinicMiamiFlorida33126-
San Marcus Research Clinic, Inc.MiamiFlorida33015-
Ocean Blue Medical Research Center, Inc.Miami SpringsFlorida33166-
Suncoast Clinical ResearchNew Port RicheyFlorida34652-
Discovery Medical Research GroupOcalaFlorida34471-
Suncoast Clinical ResearchPalm HarborFlorida34684-
University of Hawaii Clinical ResearchHonoluluHawaii96813-
Boise Kidney & Hypertension InstituteCaldwellIdaho83605-
Pacific Renal Research InstituteMeridianIdaho83642-
Cotton O'Neil ClinicTopekaKansas66606-
Univ of Kansas Schl of Medicine , WichitaWichitaKansas67214-
Penobscot Bay Medical CenterRockportMaine04854-
Nebraska Nephrology Research Institute, LLCLincolnNebraska68510-
Endocrine Group, LLPAlbanyNew York12206-
Erie County Medical Center State UniversityBuffaloNew York14215-
Institute for clinical studiesRosedaleNew York11422-
Endocrine Associates of Long Island, PCSmithtownNew York11787-
Carolina Clinical Trials LLCConcordNorth Carolina28025-
Physicians EastGreenvilleNorth Carolina27834-
Diabetes & Endocrinology Consultants PCMorehead CityNorth Carolina28557-
Boice Willis Clinic, PARocky MountNorth Carolina27804-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Partners in Nephrology & EndocrinologyPittsburghPennsylvania15224-
South Carolina Nephrology and Hypertension Center, Inc.OrangeburgSouth Carolina29118-
Carolina Diabetes & Kidney Ctr. Sumter Medical SpecialistSumterSouth Carolina29150-
Southeast Renal Research InstituteChattanoogaTennessee37408-
Knoxville Kidney Center, PLLCKnoxvilleTennessee37923-
Center For Clinical ResearchAustinTexas78758-
Endocrine Associates of DallasDallasTexas75231-
Office of Dr. Sergio RovnerEl PasoTexas79925-
Endocrine Associates, LLCHoustonTexas77004-
Juno ResearchHoustonTexas77036-
The Endocrine CenterHoustonTexas77079-
San Antonio Kidney Disease Center Physicians GroupSan AntonioTexas78229-
Providence Health & ServicesSpokaneWashington99204-

Find similar trials in Montgomery, AL

By condition
Chronic kidney diseaseType 2 diabetes
By specialty
NephrologyKidney diseaseEndocrinologyMetabolic healthWeight loss
By research site
Extended Arm Physician, Inc.· Montgomery, ALNorth American Research Institute· Azusa, CARenal Consultants Medical Group· Granada Hills, CAMarin Endocrine Associates· Greenbrae, CAAcademic Medical Research Institute· Los Angeles, CASutter Gould Medical Foundation· Modesto, CA

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