Completed

GRADEComparing Diabetes Medications for Glycemia Reduction and Patient-Centered Outcomes

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Study Aim

This study aims to compare the effectiveness of different diabetes medications in reducing blood sugar levels (HbA1c) while considering patient-centered outcomes, in individuals currently taking metformin.

What is being tested

Sulfonylurea (glimepiride)

+ DPP-4 inhibitor (sitagliptin)

+ GLP-1 receptor agonist (liraglutide)

Drug
Who is being recruted

Diabetes Mellitus+3

+ Endocrine System Diseases

+ Metabolic Diseases

Over 30 Years
+36 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorGRADE Study Group
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

The study focuses on comparing different diabetes medications that are often used in combination with metformin. The main goal is to evaluate how well these medications lower blood sugar levels and improve patient-centered outcomes. This research targets individuals with diabetes who are currently taking metformin but need additional support to manage their blood sugar levels. The importance of this study lies in its potential to identify the most effective medication combinations, ultimately improving diabetes care and addressing the challenges associated with blood sugar management.

NCT01794143
Principal SponsorGRADE Study Group
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7850 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 2

Criteria

8 inclusion criteria required to participate
A negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile)
Duration of diagnosed diabetes < 10 years
Fluent in either English or Spanish
HbA1c criteria (at final run-in visit, ~2 weeks prior to randomization): 6.8-8.5%
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28 exclusion criteria prevent from participating
A life-threatening event within 30 days prior to screening or currently planned major surgery
Any major cardiovascular event in previous year, including history of myocardial infarction, stroke, or vascular procedure such as coronary artery or peripheral bypass grafting, stent placements (peripheral or coronary) or angioplasty
Clinically or medically unstable with expected survival < 1 year
Current alcoholism or excessive alcohol intake
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Sulfonylurea

Group II

Active Comparator
DPP-4 inhibitor (sitagliptin)

Group III

Active Comparator
GLP-1 receptor agonist (liraglutide)

Group IV

Active Comparator
Insulin (glargine), Lantus

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 36 locations

University of Alabama-Birmingham

Birmingham, United StatesOpen University of Alabama-Birmingham in Google Maps

Southwestern American Indian Center

Phoenix, United States

Veterans Medical Research Foundation, San Diego (San Diego VA)

San Diego, United States

University of Colorado

Denver, United States
Completed36 Study Centers