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PREVAIL
CompletedPhase 3Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
105
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥23•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsMean beta-cell function over the 8-week treatment period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)
Time frame:8 weeks
descriptive
Baseline-adjusted beta-cell function at 20 weeks
Time frame:20 weeks
change from baseline, improvement
Baseline-adjusted glycemic control at 20 weeks
Time frame:20 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Baseline-adjusted glycemic control at 8 weeks
Time frame:8 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Baseline-adjusted insulin sensitivity at 8 weeks
Time frame:8 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Baseline-adjusted insulin sensitivity at 20 weeks
Time frame:20 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointEndothelial 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
- Cardiovascular diabetology2023 Mar 9PMID36894921doi:10.1186/s12933-023-01781-zvia clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.