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
As posted on ClinicalTrials.gov (NCT00775684), updated at source Jun 7, 2022. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Measure | Exenatiden=14 | Sitagliptinn=12 | Glimepiriden=14 |
|---|---|---|---|
| Acute Insulin Response (AIRmax)Baseline | 214(60) | 149(20) | 133(19) |
| Acute Insulin Response (AIRmax) 6 Months | 188.5(34.6) | 158.3(30.3) | 202.5(35.1) |
| Measure | Exenatiden=14 | Sitagliptinn=12 | Glimepiriden=14 |
|---|---|---|---|
| Acute Glucose Response (AGRmin) Baseline | 51(12) | 55(8) | 37(6) |
| Acute Glucose Response (AGRmin) 6 Months | 52(12) | 59(19) | 59(8) |
| Measure | AIRarg Exenatiden=14 | AIRarg Sitagliptinn=12 | AIRarg Glimepiriden=14 |
|---|---|---|---|
| Acute Insulin Response (AIRarg) Baseline | 52(14) | 35(4) | 44(6) |
| Acute Insulin Response (AIRarg) 6 Months | 52(11) | 34(6) | 42(4) |
| Measure | M/I Exenatiden=14 | M/I Sitagliptinn=12 | M/I Glimepiriden=14 |
|---|---|---|---|
| M/I Baseline | 0.3(0.1) | 0.3(0.0) | 0.3(0.1) |
| M/I 6 Months | 0.3(0.1) | 0.3(0.1) | 0.3(0.1) |
| Measure | P50 Exenatiden=14 | P50 Sitagliptinn=12 | P50 Glimepiriden=14 |
|---|---|---|---|
| PG50 Baseline | 175(13) | 226(12) | 168(17) |
| PG50 6 Months | 190(14) | 209(16) | 182(10) |
This study evaluates exenatide, sitagliptin, and glimepiride for the treatment of high blood sugar in patients with impaired fasting glucose or early type 2 diabetes. The purpose of this study is to determine if exenatide and sitagliptin increase the amount of insulin made by the pancreas compared to glimepiride. It is hypothesized that exenatide or sitagliptin will sustain or increase the amount of insulin made by the pancreas in comparison to glimepiride.
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.