Effects of Saxagliptin on Endothelial Function (ESENDI)
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|ClinicalTrials.gov Identifier: NCT01319357|
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : February 12, 2014
Diabetes mellitus is a metabolic disease with a growing prevalence worldwide. Currently available therapies for type 2 diabetes have various limitations and are associated with increased risk of hypoglycemia, weight gain, gastrointestinal side effects or edema and heart failure.
A new and promising class of drugs are the gliptins. Several efficacy studies demonstrated a significant improvement of HbA1c with gliptins. In addition, gliptins improved fasting as well as prandial glucose levels and did not induce weight gain. Due to these positive metabolic effects in combination with a very small spectrum of side effects gliptins might very well be part of the standard therapy for type 2 diabetes in the future.
Apart form surrogate parameters like reduction of fasting and postprandial blood glucose levels or improvement of HbA1c, the effect of gliptins on micro- and macrovascular function and cardiovascular outcome has not been the primary focus of current studies. Diabetes mellitus is strongly associated with microangiopathy and macroangiopathy and is a strong independent risk factor for cardiovascular disease and cardiovascular mortality. Endothelial dysfunction which plays a crucial role in the atherosclerotic process is commonly observed in patients with diabetes mellitus and already prediabetes and has - amongst other factors - been linked to fasting and postprandial hyperglycemia. Taken into account that gliptins reduce hyperglycemia and hyperglycemic peaks by preventing inactivation of GLP-1, which exerted beneficial effects on the endothelium in previous studies it is of major interest whether therapy with gliptins improves endothelial function.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2||Drug: Saxagliptin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Saxagliptin on Endothelial Function in Patients With Type 2 Diabetes|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Placebo Comparator: Placebo
orally for 6 weeks
Active Comparator: Saxagliptin
saxagliptin 5 mg/day during 6 weeks
orally 5 mg/d for 6 weeks
Other Name: Onglyza
- effect of saxagliptin compared to placebo on endothelial and vascular function of the retinal circulation [ Time Frame: after 6 weeks of treatment with saxagliptin vs. 6 weeks of treatment with placebo (12 weeks in all) ]retinal circulation. By applying Scanning-Laser-Doppler-Flowmetry, the change of retinal capillary flow after i.v. L-NMMA application
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319357
|Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg|
|Erlangen, Germany, 91054|
|Principal Investigator:||Roland E Schmieder, MD||University of Erlangen-Nürnberg|