N/A
N=47
Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
Pre-diabetes · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00775684 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) — 214; 149; 133; 188.5 μU/ml — p==0.1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exenatide (Drug); Sitagliptin (Drug); Glimepiride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) |
214; 149; 133; 188.5; 158.3; 202.5 | =0.1 |
| PRIMARY Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL) |
51; 55; 37; 52; 59; 59 | — |
| SECONDARY Change in Acute Insulin Response to Arginine. (AIRarg) |
52; 35; 44; 52; 34; 42 | >0.1 |
| SECONDARY Insulin Sensitivity at Baseline and 6 Months |
0.3; 0.3; 0.3; 0.3; 0.3; 0.3 | >0.1 |
| SECONDARY 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 |
175; 226; 168; 190; 209; 182 | >0.1 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Male and female patients age 18 to 70 years.
- Ability to provide written informed consent
- Mentally stable and able to comply with the procedures of the study protocol
- 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)
- Stable body weight (+ 5%) for at least 2 weeks
- Female Patients: Agree to use adequate contraception if reproductively capable. Adequate contraception includes either a hormonal or barrier method, or surgical sterilization.
Exclusion Criteria
- Diagnosis of type 1 diabetes
- Receiving insulin, exenatide (Byetta®), or sitagliptin (Januvia®) treatment or taking > 2 oral anti-diabetogenic agents for the treatment of diabetes
- BMI > 44 kg/m2
- Allergy to any sulfa-containing compounds
- Uncontrolled hypertension (Systolic Blood Pressure >160 or Diastolic Blood Pressure > 100 mmHg)
- Uncontrolled hyperlipidemia (triglycerides > 500 or LDL > 160 mg/dl)
- Elevation of liver function tests > 2 times the upper limit of normal
- Estimated Glomerular Filtration Rate (GFR) 5.5 mmol/L)
- Moderate anemia (hemoglobin concentration < 12 g/dl in men and < 11 g/dl in women)
- Female patients: pregnant or lactating
- Hepatic cirrhosis
- Known active alcohol or substance abuse
- Active cardiovascular disease
- Use of any investigational agent within 6 weeks of the baseline visit
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
Data sourced from ClinicalTrials.gov (NCT00775684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.