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Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
A Randomized, Controlled Trial Comparing the Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass in Patients With Impaired Fasting Glucose or Early Type 2 Diabetes
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
3
Recruiting sites
—
Enrollment
47
actual
Study population
Prediabetes / glucose intolerance, Type 2 diabetes
Key I/E criterion
—
Primary endpoint
•Effect on Functional Beta-cell Mass
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. Male and female patients age 18 to 70 years.
2. Ability to provide written informed consent
3. Mentally stable and able to comply with the procedures of the study protocol
4. Clinical history compatible with impaired fasting glucose or early T2D as defined by a plasma glucose concentration between 110-159 mg/dl following a 12 hour overnight fast performed off any anti-diabetogenic agent for at least 2 weeks (6 weeks for thiazolidinediones)
5. Stable body weight (+ 5%) for at least 2 weeks
6. Female Patients: Agree to use adequate contraception if reproductively capable. Adequate contraception includes either a hormonal or barrier method, or surgical sterilization.
Exclusion criteria
1. Diagnosis of type 1 diabetes
2. Receiving insulin, exenatide (Byetta®), or sitagliptin (Januvia®) treatment or taking > 2 oral anti-diabetogenic agents for the treatment of diabetes
3. BMI > 44 kg/m2
4. Allergy to any sulfa-containing compounds
5. Uncontrolled hypertension (Systolic Blood Pressure >160 or Diastolic Blood Pressure > 100 mmHg)
6. Uncontrolled hyperlipidemia (triglycerides > 500 or LDL > 160 mg/dl)
7. Elevation of liver function tests > 2 times the upper limit of normal
8. Estimated Glomerular Filtration Rate (GFR) < 55 ml/min/1.73m2 (46)
9. Hyperkalemia (serum potassium > 5.5 mmol/L)
10. Moderate anemia (hemoglobin concentration < 12 g/dl in men and < 11 g/dl in women)
11. Female patients: pregnant or lactating
12. Hepatic cirrhosis
13. Known active alcohol or substance abuse
14. Active cardiovascular disease
15. Use of any investigational agent within 6 weeks of the baseline visit
16. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
Endpoints (5)
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
5 endpointsEffect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml)
Time frame:Baseline and 6 months
change from baseline, improvement
Posted result
| Group | Value (mean), μU/ml | 95% CI |
|---|---|---|
| ExenatideAcute Insulin Response (AIRmax)Baseline | 214 | — |
| Acute Insulin Response (AIRmax) 6 Months | 188.5 | — |
| SitagliptinAcute Insulin Response (AIRmax)Baseline | 149 | — |
| Acute Insulin Response (AIRmax) 6 Months | 158.3 | — |
| GlimepirideAcute Insulin Response (AIRmax)Baseline | 133 | — |
| Acute Insulin Response (AIRmax) 6 Months | 202.5 | — |
Student t test
Repeated measure (baseline and 6 months)
Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL)
Time frame:Baseline and 6 months
change from baseline, improvement
Posted result
| Group | Value (mean), pg/mL | 95% CI |
|---|---|---|
| ExenatideAcute Glucose Response (AGRmin) Baseline | 51 | — |
| Acute Glucose Response (AGRmin) 6 Months | 52 | — |
| SitagliptinAcute Glucose Response (AGRmin) Baseline | 55 | — |
| Acute Glucose Response (AGRmin) 6 Months | 59 | — |
| GlimepirideAcute Glucose Response (AGRmin) Baseline | 37 | — |
| Acute Glucose Response (AGRmin) 6 Months | 59 | — |
Change in Acute Insulin Response to Arginine. (AIRarg)
Time frame:Baseline and 6 months
change from baseline, improvement
Posted result
| Group | Value (mean), uU/mL | 95% CI |
|---|---|---|
| AIRarg ExenatideAcute Insulin Response (AIRarg) Baseline | 52 | — |
| Acute Insulin Response (AIRarg) 6 Months | 52 | — |
| AIRarg SitagliptinAcute Insulin Response (AIRarg) Baseline | 35 | — |
| Acute Insulin Response (AIRarg) 6 Months | 34 | — |
| AIRarg GlimepirideAcute Insulin Response (AIRarg) Baseline | 44 | — |
| Acute Insulin Response (AIRarg) 6 Months | 42 | — |
Within group changes over 6 months (delta= final - baseline) were compared.
Insulin Sensitivity at Baseline and 6 Months
Time frame:Baseline and 6 months
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Value (mean), ((mg/kg) /min) /uU/mL | 95% CI |
|---|---|---|
| M/I ExenatideM/I Baseline | 0.3 | — |
| M/I 6 Months | 0.3 | — |
| M/I SitagliptinM/I Baseline | 0.3 | — |
| M/I 6 Months | 0.3 | — |
| M/I GlimepirideM/I Baseline | 0.3 | — |
| M/I 6 Months | 0.3 | — |
PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months
Time frame:Baseline and 6 months
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| P50 ExenatidePG50 Baseline | 175 | — |
| PG50 6 Months | 190 | — |
| P50 SitagliptinPG50 Baseline | 226 | — |
| PG50 6 Months | 209 | — |
| P50 GlimepiridePG50 Baseline | 168 | — |
| PG50 6 Months | 182 | — |
Publications (7)
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
- Diabetes care2006 Mar (month)PMID16505537doi:10.2337/diacare.29.03.06.dc05-1538via CT.gov background
- The Journal of clinical endocrinology and metabolism2001 Sep (month)PMID11549624doi:10.1210/jcem.86.9.7713via CT.gov background
- Diabetes1995 Nov (month)PMID7589820via CT.gov background
- The Journal of clinical investigation1984 Oct (month)PMID6384269doi:10.1172/JCI111542via CT.gov background
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.