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

NCT01794143 · Completed

Last updated 2026-05-28

This study compares how different diabetes medications work when added to metformin in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 7,850 people

Who can join Ages 30+ · all sexes

Timeline Started 2013-05 · est. completion 2021-04

Where 36 sites · United States

What this study is testing ClinicalTrials.gov NCT01794143 ↗

Description as written by the study sponsor.

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.

Treatments tested

Sulfonylurea (glimepiride) also known as Glimepiride Drug

Used in accordance with labeling and/or usual practice.
DPP-4 inhibitor (sitagliptin) also known as Sitagliptin Drug

Used in accordance with labeling and/or usual practice
GLP-1 receptor agonist (liraglutide) also known as Liraglutide Drug

Used in accordance with labeling and/or usual practice.
Insulin (glargine) also known as Lantus Drug

Used in accordance with labeling and/or usual practice.

Main thing measured	Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication
Sponsor	GRADE Study Group
Conditions studied	Type 2 Diabetes, Comparative Effectiveness of Glycemia-lowering Medications
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01794143 ↗