A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
GRADE Study Group
Study ID
NCT01794143
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Sulfonylurea (glimepiride) — DRUG
    Used in accordance with labeling and/or usual practice.
  • DPP-4 inhibitor (sitagliptin) — DRUG
    Used in accordance with labeling and/or usual practice
  • GLP-1 receptor agonist (liraglutide) — DRUG
    Used in accordance with labeling and/or usual practice.
  • Insulin (glargine) — DRUG
    Used in accordance with labeling and/or usual practice.

Study Details

The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.

Key Dates

Start date
May 31, 2013
Status verified
Jan 2026
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
7,850 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Sulfonylurea (glimepiride)
    Sulfonylurea
  • Active Comparator: DPP-4 inhibitor
    DPP-4 inhibitor (sitagliptin)
  • Active Comparator: GLP-1 receptor agonist
    GLP-1 receptor agonist (liraglutide)
  • Active Comparator: Insulin (glargine)
    Insulin (glargine), Lantus

Primary Outcome Measure

Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication [ Time Frame: Quarterly for 4 to 7 years ]

Locations (36)

FacilityCityStateZIPSite coordinators
University of Alabama-BirminghamBirminghamAlabama--
Southwestern American Indian CenterPhoenixArizona--
Veterans Medical Research Foundation, San Diego (San Diego VA)San DiegoCalifornia--
University of ColoradoDenverColorado--
Yale University School of MedicineNew HavenConnecticut--
South Florida VA Foundation (Miami VA)MiamiFlorida--
Atlanta VA Medical CenterDecaturGeorgia--
Kaiser Permanente of GeorgiaDuluthGeorgia--
Pacific Health Research and Education Institute (VA Pacific Islands)HonoluluHawaii--
Indiana University School of MedicineIndianapolisIndiana--
University of IowaIowa CityIowa--
Pennington Biomedical Research CenterBaton RougeLouisiana--
MedStar Health Research InstituteHyattsvilleMaryland--
Massachusetts General HospitalBostonMassachusetts--
University of MichiganAnn ArborMichigan--
International Diabetes CenterMinneapolisMinnesota--
University of MinnesotaMinneapolisMinnesota--
Washington University School of MedicineSt LouisMissouri--
University of NebraskaOmahaNebraska--
University of New Mexico School of MedicineAlbuquerqueNew Mexico--
State University of New York (SUNY)-Downstate Medical CenterBrooklynNew York--
Columbia University Naomi Berrie Diabetes CenterNew YorkNew York--
Mount Sinai St. Luke's HospitalNew YorkNew York--
Albert Einstein College of MedicineThe BronxNew York--
Duke University Medical CenterDurhamNorth Carolina--
University of North Carolina Diabetes Care CenterDurhamNorth Carolina--
University of CincinnatiCincinnatiOhio--
Case Western Reserve University School of MedicineClevelandOhio--
Kaiser Permanente NorthwestPortlandOregon--
Oregon Health and Science UniversityPortlandOregon--
Vanderbilt University Medical CenterNashvilleTennessee--
Baylor Endocrine CenterDallasTexas--
University of Texas-Southwestern Medical CenterDallasTexas--
Baylor College of MedicineHoustonTexas--
University of Texas Health Science CenterSan AntonioTexas--
Seattle Institute for Biomedical and Clinical ResearchSeattleWashington--

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Alabama-Birmingham· Birmingham, ALSouthwestern American Indian Center· Phoenix, AZVeterans Medical Research Foundation, San Diego (San Diego VA)· San Diego, CAUniversity of Colorado· Denver, COYale University School of Medicine· New Haven, CTSouth Florida VA Foundation (Miami VA)· Miami, FL

Related Studies