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PREVAIL

CompletedPhase 3

Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

105

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI ≥23HbA1c 5.5-9%

Primary endpoint

Mean beta-cell function over the 8-week treatment period, measured

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 IDNCT02194595
Org study ID14-0128-A

Timeline

Milestones

Study first posted2014-07-18estimated
Last update posted2022-04-11actual
Study start2014-09 (month precision)
Primary completion2021-12actual (month precision)
Study completion2022-02actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Men and women between the ages of 30 and 80 years inclusive

2. T2DM diagnosed by a physician ≤7 years prior to enrolment

3. On 0-2 anti-diabetic medications, with no change in dose/regimen in the preceding 4 weeks

4. A1c at screening between 5.5% and 9.0% inclusive if on anti-diabetic medications, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication

5. BMI ≥ 23 kg/m2

6. Negative pregnancy test at recruitment for all women with childbearing potential

Exclusion criteria

1. Current anti-diabetic treatment with insulin or a glucagon-like peptide-1 (GLP-1) agonist

2. Type 1 diabetes or secondary forms of diabetes

3. History of hypoglycemia unawareness or severe hypoglycemia requiring assistance

4. Hypersensitivity to insulin, exenatide, or the formulations of these products

5. Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula

6. History of pancreatitis

7. Family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (MTC)

8. Personal history of non-familial medullary thyroid carcinoma (MTC)

9. Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)

10. Unwillingness to perform capillary glucose monitoring at least 4 times a day during treatment

11. Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide.

12. Any factor likely to limit adherence to the protocol, in the opinion of investigator

Endpoints (7)

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.

Coverage by outcome category

Glycemic / diabetes
6
Cardiometabolic biomarkers
1

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Mean beta-cell function over the 8-week treatment period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)

Time frame:8 weeks

descriptive

Secondary/protocol endpoint

Baseline-adjusted beta-cell function at 20 weeks

Time frame:20 weeks

change from baseline, improvement

Secondary/protocol endpoint

Baseline-adjusted glycemic control at 20 weeks

Time frame:20 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Baseline-adjusted glycemic control at 8 weeks

Time frame:8 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Baseline-adjusted insulin sensitivity at 8 weeks

Time frame:8 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Baseline-adjusted insulin sensitivity at 20 weeks

Time frame:20 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Endothelial function at 8 weeks

Time frame:8 weeks

ratio, improvement

Publications (1)

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 tableno registry results posted yet

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.