DelfaGLP-1 Atlas

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GRADE

CompletedPhase 3Results posted

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

Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study

Lead sponsor

GRADE Study Group

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

36

Recruiting sites

—

Enrollment

7,850

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 6.8-8.5%

Primary endpoint

•HbA1c <7.0% achievement

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01794143
Org study IDGRADE
Secondary ID1U01DK098246-01

Timeline

Milestones

Study first posted2013-02-18estimated
Primary completion2021-04-30actual
Study completion2021-04-30actual
Last update posted2026-02-10actual
Results first posted2026-02-10actual
Study start2013-05 (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-allLiraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

8 endpoints
Primary/registry result

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

Time frame:Quarterly for 4 to 7 years

HbA1c <7.0% achievement

time to event, event

LOINC 4548-4

Posted result

GroupValue (median), years95% CI
Glargine Insulin U-1001.30.6 – 2.5
Glimepiride1.30.6 – 2.3
Liraglutide1.50.6 – 2.7
Sitagliptin0.80.5 – 2.0
Primary/registry result

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

Time frame:Quarterly, 4-7 years

HbA1c <7.0% achievement

threshold achievement, event

LOINC 4548-4

Posted result

GroupValue (count_of_participants), Participants95% CI
Glargine Insulin U-100852—
Glimepiride908—
Liraglutide860—
Sitagliptin981—
Primary/protocol endpoint

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

Time frame:Quarterly for 4 to 7 years

HbA1c <7.0% achievement

time to event, event

LOINC 4548-4

Primary/protocol endpoint

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

Time frame:Quarterly, 4-7 years

HbA1c <7.0% achievement

threshold achievement, event

LOINC 4548-4

Secondary/registry result/low confidence

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

Time frame:Quarterly, 4-6 years

time to event, event

LOINC 4548-4

Posted result

GroupValue (median), years95% CI
Glargine Insulin U-1002.11.0 – 3.5
Glimepiride2.01.1 – 3.3
Liraglutide2.21.0 – 3.5
Sitagliptin1.70.8 – 3.0
Secondary/registry result

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

Time frame:Quarterly for 4 to 7 years

threshold achievement, event

LOINC 4548-4

Posted result

GroupValue (count_of_participants), Participants95% CI
Glargine Insulin U-100498—
Glimepiride633—
Liraglutide583—
Sitagliptin697—
Secondary/protocol endpoint

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

Time frame:Quarterly, 4-6 years

time to event, event

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Quarterly for 4 to 7 years

threshold achievement, event

LOINC 4548-4

Publications (60)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.