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CompletedPhase NAResults posted

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

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

NCT IDNCT00775684
Org study ID808425

Timeline

Milestones

Study first posted2008-10-20estimated
Results first posted2017-12-06actual
Last update posted2022-06-07actual
Study start2008-10 (month precision)
Primary completion2012-11actual (month precision)
Study completion2012-11actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Prediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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 endpoints
Primary/protocol endpoint

Effect 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

GroupValue (mean), μU/ml95% CI
ExenatideAcute Insulin Response (AIRmax)Baseline214
Acute Insulin Response (AIRmax) 6 Months188.5
SitagliptinAcute Insulin Response (AIRmax)Baseline149
Acute Insulin Response (AIRmax) 6 Months158.3
GlimepirideAcute Insulin Response (AIRmax)Baseline133
Acute Insulin Response (AIRmax) 6 Months202.5
p=0.1t-test, 2 sided

Student t test

p< 0.05t-test, 2 sided

Repeated measure (baseline and 6 months)

Primary/protocol endpoint/low confidence

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

GroupValue (mean), pg/mL95% CI
ExenatideAcute Glucose Response (AGRmin) Baseline51
Acute Glucose Response (AGRmin) 6 Months52
SitagliptinAcute Glucose Response (AGRmin) Baseline55
Acute Glucose Response (AGRmin) 6 Months59
GlimepirideAcute Glucose Response (AGRmin) Baseline37
Acute Glucose Response (AGRmin) 6 Months59
Secondary/protocol endpoint

Change in Acute Insulin Response to Arginine. (AIRarg)

Time frame:Baseline and 6 months

change from baseline, improvement

Posted result

GroupValue (mean), uU/mL95% CI
AIRarg ExenatideAcute Insulin Response (AIRarg) Baseline52
Acute Insulin Response (AIRarg) 6 Months52
AIRarg SitagliptinAcute Insulin Response (AIRarg) Baseline35
Acute Insulin Response (AIRarg) 6 Months34
AIRarg GlimepirideAcute Insulin Response (AIRarg) Baseline44
Acute Insulin Response (AIRarg) 6 Months42
p>0.1t-test, 1 sided

Within group changes over 6 months (delta= final - baseline) were compared.

Secondary/protocol endpoint

Insulin Sensitivity at Baseline and 6 Months

Time frame:Baseline and 6 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (mean), ((mg/kg) /min) /uU/mL95% CI
M/I ExenatideM/I Baseline0.3
M/I 6 Months0.3
M/I SitagliptinM/I Baseline0.3
M/I 6 Months0.3
M/I GlimepirideM/I Baseline0.3
M/I 6 Months0.3
p>0.1t-test, 1 sided
Secondary/protocol endpoint

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

GroupValue (mean), mg/dL95% CI
P50 ExenatidePG50 Baseline175
PG50 6 Months190
P50 SitagliptinPG50 Baseline226
PG50 6 Months209
P50 GlimepiridePG50 Baseline168
PG50 6 Months182
p>0.1t-test, 1 sided

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.

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.