A Phase 4 interventional study of Exenatide and Metformin in Impaired Glucose Tolerance, sponsored by St. Paul Heart Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-08.
Sponsored by St. Paul Heart Clinic · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.
792 studies on the registry are indexed under Glucose Intolerance; 126 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 656 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →St. Paul Heart Clinic is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Drug: Exenatide
Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Drug: Metformin
Change in Reactive Hyperemic Index Over the 3-month Treatment Period
Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.
Time frame: Change from baseline to 3 months
Patients were recruited from medical clinics
| Milestone | Exenatide | Metformin |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.
| ratio | Exenatide | Metformin |
|---|---|---|
| Change in Reactive Hyperemic Index Over the 3-month Treatment Period | 0.01 ± 0.68 | -0.17 ± 0.72 |
Collected over 3-months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exenatide | — | 0/25 (0%) | 0/25 (0%) |
| Metformin | — | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Exenatide | Metformin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 25 | 50 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Exenatide | Metformin | Total |
|---|---|---|---|
| Mean | 58.7 ± 10 | 58.4 ± 10.1 | 58.5 ± 10.0 |
| Sex: Female, Male(Participants) | Exenatide | Metformin | Total |
|---|---|---|---|
| Female | 20 | 18 | 38 |
| Male | 5 | 7 | 12 |
| Region of Enrollment(participants) | Exenatide | Metformin | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
The record gives a start of Oct 2007, a primary completion of Jul 2011 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2013, 2 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Exenatide
St. Paul Heart Clinic