Status:
COMPLETED
Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Pennsylvania Department of Health
Conditions:
Pre-diabetes
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 d...
Detailed Description
The incidence of type 2 diabetes (T2D) has reached epidemic proportions throughout the world. In the United States more than 1.5 million new cases of diabetes were diagnosed in 2005, and the estimated...
Eligibility Criteria
Inclusion
- 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
- 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) \< 55 ml/min/1.73m2 (46)
- Hyperkalemia (serum potassium \> 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00775684
Start Date
October 1 2008
End Date
November 1 2012
Last Update
June 7 2022
Active Locations (3)
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1
Clinical and Translational Research Center, Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Rodebaugh Diabetes Center, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107