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

NCT01794143 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7850

Last updated 2026-02-10

Study results available
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Summary

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.

Conditions

  • Type 2 Diabetes
  • Comparative Effectiveness of Glycemia-lowering Medications

Interventions

DRUG

Sulfonylurea (glimepiride)

Used in accordance with labeling and/or usual practice.

DRUG

DPP-4 inhibitor (sitagliptin)

Used in accordance with labeling and/or usual practice

DRUG

GLP-1 receptor agonist (liraglutide)

Used in accordance with labeling and/or usual practice.

DRUG

Insulin (glargine)

Used in accordance with labeling and/or usual practice.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Centers for Disease Control and Prevention

    collaborator FED

  • GRADE Study Group

    lead OTHER

Principal Investigators

  • David M Nathan, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01794143 on ClinicalTrials.gov