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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name GRADE

NCTNCT01794143 (opens ClinicalTrials.gov in a new tab)Other idGRADEOther id1U01DK098246-01

Overview

Status
Completed
Phase
Phase 3
Enrollment
7,850 participants (actual)
Sponsor
GRADE Study Group · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2013
Primary completion
30 Apr 2021
Completion
30 Apr 2021
First posted
18 Feb 2013 (estimated)
Last update posted
10 Feb 2026
Conditions
Type 2 Diabetes · Comparative Effectiveness of Glycemia-lowering Medications

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. Ph 3

    GRADE

    NCT01794143

    May 2013 to 30 Apr 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Sulfonylurea (glimepiride)Drug
  • DPP-4 inhibitor (sitagliptin)Drug
  • GLP-1 receptor agonist (liraglutide)Drug
  • Insulin (glargine)Drug

Arms4

  • 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 outcomes2

Outcomes the sponsor listed as primary.

  1. Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication

    Time frame · Quarterly for 4 to 7 years

    Registry description

    The primary metabolic outcome is the time to primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed, after addition of randomly assigned glucose-lowering medication at baseline.

  2. HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication

    Time frame · Quarterly, 4-7 years

    Registry description

    Number of participants who reached primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed, after addition of randomly assigned glucose-lowering medication at baseline.

Secondary outcomes(2)
  1. Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication.

    Time frame · Quarterly, 4-6 years

    Registry description

    The secondary metabolic outcome is time to HbA1c\>7.5% (58 mmol/mol), confirmed, after addition of randomly assigned glucose-lowering medication at baseline.

  2. HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication.

    Time frame · Quarterly for 4 to 7 years

    Registry description

    Number of participants who reached primary failure defined as an HbA1c\>7.5% (58 mmol/mol), confirmed, after addition of randomly assigned glucose-lowering medication at baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Quarterly for 4 to 7 years

Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication

GroupValue (years)
Glargine Insulin U-1001.3
Glimepiride1.3
Liraglutide1.5
Sitagliptin0.8
Primary outcomeCount of participants· Quarterly, 4-7 years

HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication

GroupValue (Participants)
Glargine Insulin U-100852
Glimepiride908
Liraglutide860
Sitagliptin981
Secondary and other outcome results(2)
Secondary outcomeMedian· Quarterly, 4-6 years

Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication.

GroupValue (years)
Glargine Insulin U-1002.1
Glimepiride2.0
Liraglutide2.2
Sitagliptin1.7
Secondary outcomeCount of participants· Quarterly for 4 to 7 years

HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication.

GroupValue (Participants)
Glargine Insulin U-100498
Glimepiride633
Liraglutide583
Sitagliptin697

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Glargine Insulin U-100Glargine Insulin U-100 was administered daily at an initial dose of up to 20 U and adjusted according to glucose levels monitored by the participant and to avoid hypoglycemia.42 / 1263259 / 12630 / 1263
GlimepirideSulfonylurea glimepiride was increased from 1 to 2 mg to a maximum of 8 mg per day, administered in divided doses and adjusted according to glucose levels monitored by the participant and to avoid hypoglycemia.43 / 1254315 / 12540 / 1254
LiraglutideGLP-1 analog liraglutide was initiated at a dose of 0.6 mg, with escalation to a maximum dose of 1.8 mg daily, depending on gastrointestinal side effects.27 / 1262204 / 12620 / 1262
SitagliptinDPP-4 inhibitor sitagliptin was initiated at a dose of 100 mg, with the dose adjusted according to kidney function.41 / 1268272 / 12680 / 1268
Study Run-In (Metformin Only)During a run-in period of 6 to 14 weeks before randomization, the metformin dose was increased to a minimum of 1000 mg per day, with a target maximal dose (one that could be taken without unacceptable side effects) of 2000 mg per day.0 / 78501 / 78500 / 7850

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies22

Studies that cite this trial.

Studies with results

17 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results

Indexing hint: Randomized controlled trial · 2025

9 results

Differential Treatment Effects on β-Cell Function Using Model-Based Parameters in Type 2 Diabetes: Results From the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Utzschneider et al. 2025Diabetes carecited by 2

PMID 39998948PMC11932811DOI 10.2337/dc24-2419PUB-39998948

Rights unknown9 results

Indexing hint: Randomized controlled trial · 2025

9 results

Weight Gain Was Associated With Worsening Glycemia and Cardiovascular and Kidney Outcomes in Patients With Type 2 Diabetes Independent of Diabetes Medication in the GRADE Randomized Controlled Trial.

Wexler et al. 2025Diabetes carecited by 7

PMID 40267365PMC12094209DOI 10.2337/dc24-2825PUB-40267365

Rights unknown9 results

Indexing hint: Randomized controlled trial · 2025

9 results

Glucose-Lowering Medications, Glycemia, and Cognitive Outcomes: The GRADE Randomized Clinical Trial.

Luchsinger et al. 2025JAMA internal medicinecited by 6

PMID 40388190PMC12090067DOI 10.1001/jamainternmed.2025.1189PUB-40388190

Rights unknown9 results

Indexing hint: Randomized controlled trial · 2025

13 results

Association of Hospitalizations With Randomized Glycemia-Lowering Treatment in GRADE.

Hsia et al. 2025Diabetes care

PMID 40424051PMC12178615DOI 10.2337/dc24-2839PUB-40424051

Rights unknown13 results

Indexing hint: Randomized controlled trial · 2025

4 results

Differences in Prevalence and Incidence of Electrocardiogram Abnormalities and Cardiovascular Autonomic Neuropathy Among Randomized Glucose-Lowering Treatments in Early Type 2 Diabetes: The Glycemia Reduction Approaches in Diabetes (GRADE) Cohort.

Pop-Busui et al. 2025Diabetes care

PMID 40986645PMC12583396DOI 10.2337/dc25-1087PUB-40986645

Rights unknown4 results

Indexing hint: Randomized controlled trial · 2024

3 results

The Use of Rescue Insulin in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Hollander et al. 2024Diabetes carecited by 5

PMID 37756542PMC10973913DOI 10.2337/dc23-0516PUB-37756542

Rights unknown3 results

Indexing hint: Randomized controlled trial · 2024

6 results

Impact of Insulin Sensitivity and β-Cell Function Over Time on Glycemic Outcomes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE): Differential Treatment Effects of Dual Therapy.

Utzschneider et al. 2024Diabetes carecited by 5

PMID 38190619PMC10973903DOI 10.2337/dc23-1059PUB-38190619

Rights unknown6 results

Indexing hint: Randomized controlled trial · 2024

6 results

Impact of Glucose-Lowering Medications on Health-Related Quality of Life in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Cherrington et al. 2024Diabetes carecited by 4

PMID 38190625PMC10973906DOI 10.2337/dc23-1648PUB-38190625

Rights unknown6 results

Indexing hint: Randomized controlled trial · 2024

8 results

Comparative Effects of Randomized Second-line Therapy for Type 2 Diabetes on a Composite Outcome Incorporating Glycemic Control, Body Weight, and Hypoglycemia: An Analysis of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Kirkman et al. 2024Diabetes carecited by 5

PMID 38194519PMC10973908DOI 10.2337/dc23-1332PUB-38194519

Rights unknown8 results

Indexing hint: Randomized controlled trial · 2024

5 results

Longitudinal Effects of Glucose-Lowering Medications on β-Cell Responses and Insulin Sensitivity in Type 2 Diabetes: The GRADE Randomized Clinical Trial.

Rasouli et al. 2024Diabetes carecited by 20

PMID 38211595PMC10973918DOI 10.2337/dc23-1070PUB-38211595

Rights unknown5 results

Indexing hint: Randomized controlled trial · 2024

2 results

Association of Baseline Factors With Glycemic Outcomes in GRADE: A Comparative Effectiveness Randomized Clinical Trial.

Garvey et al. 2024Diabetes carecited by 12

PMID 38285957PMC10973909DOI 10.2337/dc23-1782PUB-38285957

Rights unknown2 results

Indexing hint: Randomized controlled trial · 2024

6 results

Cardiovascular Outcomes in GRADE (Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness Study).

Green et al. 2024Circulationcited by 22

PMID 38344820PMC10978227DOI 10.1161/circulationaha.123.066604PUB-38344820

Rights unknown6 results

Indexing hint: Randomized controlled trial · 2024

2 results

Glycemia reduction in type 2 diabetes-Hypoglycemia outcomes: A randomized clinical trial.

Seaquist et al. 2024PloS onecited by 4

PMID 39546502PMC11567630DOI 10.1371/journal.pone.0309907PUB-39546502

Rights unknown2 results

Indexing hint: Randomized controlled trial · 2023

4 results

Comparative Effects of Glucose-Lowering Medications on Kidney Outcomes in Type 2 Diabetes: The GRADE Randomized Clinical Trial.

Wexler et al. 2023JAMA internal medicinecited by 24

PMID 37213109PMC10203973DOI 10.1001/jamainternmed.2023.1487PUB-37213109

Rights unknown4 results

Indexing hint: Randomized controlled trial · 2022

9 results

Glycemia Reduction in Type 2 Diabetes - Glycemic Outcomes.

The New England journal of medicinecited by 168

PMID 36129996PMC9829320DOI 10.1056/nejmoa2200433PUB-36129996

Rights unknown9 results

Indexing hint: Randomized controlled trial · 2022

9 results

Glycemia Reduction in Type 2 Diabetes - Microvascular and Cardiovascular Outcomes.

The New England journal of medicinecited by 122

PMID 36129997PMC9832916DOI 10.1056/nejmoa2200436PUB-36129997

Rights unknown9 results

Indexing hint: Randomized controlled trial · 2020

Optimization of Metformin in the GRADE Cohort: Effect on Glycemia and Body Weight.

Sivitz et al. 2020Diabetes carecited by 15

PMID 32139384PMC7171946DOI 10.2337/dc19-1769PUB-32139384

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2019

Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Wexler et al. 2019Diabetes carecited by 38

PMID 31391203PMC6804613DOI 10.2337/dc19-0901PUB-31391203

Rights unknown
Source link

More studies

3 studies on this page

PubMed tag: none · 2024

The incidence of retinopathy in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness study (GRADE).

Hsia et al. 2024Journal of diabetes and its complicationscited by 1

PMID 38354481PMC10923170DOI 10.1016/j.jdiacomp.2024.108692PUB-38354481

Rights unknown
Source link

PubMed tag: none · 2024

Differential Effects of Type 2 Diabetes Treatment Regimens on Diabetes Distress and Depressive Symptoms in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Gonzalez et al. 2024Diabetes carecited by 12

PMID 38416773PMC10973899DOI 10.2337/dc23-2459PUB-38416773

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2013

Corrected

Rationale and design of the glycemia reduction approaches in diabetes: a comparative effectiveness study (GRADE).

Nathan et al. 2013Diabetes carecited by 211

PMID 23690531PMC3714493DOI 10.2337/dc13-0356PUB-23690531

Free to read · publisher termsCC BY-NC-ND

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultPresley CA, Butera NM, Krause-Steinrauf H, Desouza CV, Hollander PA, Hoogendoorn CJ, Lagari VS, Legowski EA, Martin CL, Rasouli N, Gonzalez JS, Cherrington AL. Lack of Association of Emotional Distress With Insulin Initiation in the GRADE Randomized Diabetes Comparative Effectiveness Trial. Sci Diabetes Self Manag Care. 2025 Aug;51(4):382-393. doi: 10.1177/26350106251361363. Epub 2025 Aug 1. PMID 40751289
  • ResultNathan DM. Response to Comment on Nathan et al. Relationship Between Average Glucose Levels and HbA1c Differs Across Racial Groups: A Substudy of the GRADE Randomized Trial. Diabetes Care 2024;47:2155-2163. Diabetes Care. 2025 Mar 1;48(3):e34-e35. doi: 10.2337/dci24-0095. No abstract available. PMID 39977640
  • ResultEhrmann D, Krause-Steinrauf H, Uschner D, Wen H, Hoogendoorn CJ, Crespo-Ramos G, Presley C, Arends VL, Cohen RM, Garvey WT, Martens T, Willis HJ, Cherrington A, Gonzalez JS; GRADE Research Group. Differential associations of somatic and cognitive-affective symptoms of depression with inflammation and insulin resistance: cross-sectional and longitudinal results from the Emotional Distress Sub-Study of the GRADE study. Diabetologia. 2025 Jul;68(7):1403-1415. doi: 10.1007/s00125-025-06369-8. Epub 2025 Feb 14. PMID 39951058
  • ResultNathan DM, Herman WH, Larkin ME, Krause-Steinrauf H, Abou Assi H, Ahmann AJ, Brown-Friday J, Hsia DS, Harindhanavudhi T, Johnson M, Arends VL, Butera NM, Rosin SP, Lachin JM, Younes N; GRADE Study Research Group. Relationship Between Average Glucose Levels and HbA1c Differs Across Racial Groups: A Substudy of the GRADE Randomized Trial. Diabetes Care. 2024 Dec 1;47(12):2155-2163. doi: 10.2337/dc24-1362. PMID 39312277
  • ResultHampe CS, Shojaie A, Brooks-Worrell B, Dibay S, Utzschneider K, Kahn SE, Larkin ME, Johnson ML, Younes N, Rasouli N, Desouza C, Cohen RM, Park JY, Florez HJ, Valencia WM, Stempel R, Palmer JP, Balasubramanyam A. GAD65Abs Are Not Associated With Beta-Cell Dysfunction in Patients With T2D in the GRADE Study. J Endocr Soc. 2024 Feb 8;8(3):bvad179. doi: 10.1210/jendso/bvad179. eCollection 2024 Jan 16. PMID 38333889
  • ResultBanerji MA, Buse JB, Younes N, Krause-Steinrauf H, Ghazi A, Lee M, Park J, Pop-Busui R, Underkofler C, Fortmann SP; GRADE Research Group. Mortality in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). Diabetes Care. 2024 Apr 1;47(4):589-593. doi: 10.2337/dc23-1356. PMID 38252886
  • ResultCherrington AL, Bebu I, Krause-Steinrauf H, Hoogendoorn CJ, Crespo-Ramos G, Presley C, Naik AD, Balasubramanyam A, Gramzinski MR, Killean T, Arends VL, Gonzalez JS; GRADE Research Group. Does Emotional Distress Predict Worse Glycemic Control Over Time? Results From the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). Diabetes Care. 2024 Apr 1;47(4):620-628. doi: 10.2337/dc23-0642. PMID 38252848
  • ResultHoogendoorn CJ, Krause-Steinrauf H, Uschner D, Wen H, Presley CA, Legowski EA, Naik AD, Golden SH, Arends VL, Brown-Friday J, Krakoff JA, Suratt CE, Waltje AH, Cherrington AL, Gonzalez JS; GRADE Research Group. Emotional Distress Predicts Reduced Type 2 Diabetes Treatment Adherence in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). Diabetes Care. 2024 Apr 1;47(4):629-637. doi: 10.2337/dc23-1401. PMID 38227900

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Men or women diagnosed with diabetes at age ≥ 30 years (≥ 20 for American Indians) 2. Duration of diagnosed diabetes \< 10 years 3. HbA1c criteria (at final run-in visit, \~2 weeks prior to randomization): 6.8-8.5% 4. Taking a daily dose of ≥ 1000 mg metformin for a minimum of 8 weeks at final run-in 5. Willingness to administer daily subcutaneous injections, take a second diabetes drug after randomization, potentially initiate insulin and intensify insulin therapy if study metabolic goals are not met, perform self-monitoring of blood glucose 6. Fluent in either English or Spanish 7. A negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile) 8. Provision of signed and dated informed consent prior to any study procedures Exclusion Criteria: 1. Suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin) or "secondary" diabetes due to specific causes (e.g. previously diagnosed monogenic syndromes, pancreatic surgery, pancreatitis) 2. Current or previous (within past 6 months) treatment with any diabetes drug/glucose-lowering medication other than metformin (limited use of no longer than seven days is allowed, for example during hospitalization) 3. More than 10 years of treatment with metformin at time of randomization screening 4. History of intolerance or allergy or other contraindications to any of the proposed study medications 5. Resides in the same household with another GRADE study participant 6. Current need for any specific glucose-lowering medications solely for other conditions, for example for polycystic ovary syndrome 7. Symptomatic hyperglycemia requiring immediate therapy during screening or run-in, in the judgment of the physician 8. A life-threatening event within 30 days prior to screening or currently planned major surgery 9. 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. 10. Plans for pregnancy during the course of the study for women of child-bearing potential 11. History of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass (if banding removed, may be considered eligible after 1 year) 12. History of congestive heart failure (NYHA 3 or greater) 13. History of pancreatitis 14. History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization 15. Personal or family history of MEN-2 or family history of medullary thyroid cancer 16. Estimated GFR (eGFR) \<30 ml/min/1.73 m2 or end stage renal disease requiring renal replacement therapy 17. History of severe liver disease or acute hepatitis or ALT \> 3 times upper limit of normal 18. Current alcoholism or excessive alcohol intake 19. Previous organ transplant 20. Treatment with oral or systemic glucocorticoids (other than short-term treatment, for example for poison ivy) or disease likely to require periodic or regular glucocorticoid therapy (inhaled steroids are allowed) 21. Treatment with atypical antipsychotics 22. History of hemolytic anemia, chronic transfusion requirement, or other condition rendering HbA1c results unreliable as indicator of chronic glucose levels, or hematocrit \<35 for males and \<33 for females 23. Clinically or medically unstable with expected survival \<1 year 24. Unwillingness to permit sites to contact the PCP to communicate information about the study and the participant's data 25. No non-study PCP or inability to identify such a PCP (who will provide non-study care) by the time of final run-in 26. Participation in another interventional clinical trial 27. Previous randomization in the GRADE study 28. In the opinion of the principal investigator (PI), any other factor, including language barrier, likely to limit compliance with the protocol

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