Effects of Saxagliptin on Endothelial Function

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01319357
• Date of registration: 17/03/2011
• Prospective Registration: No
• Primary sponsor: University of Erlangen-Nürnberg Medical School
• Public title: Effects of Saxagliptin on Endothelial Function ESENDI
• Scientific title: Effects of Saxagliptin on Endothelial Function in Patients With Type 2 Diabetes
• Date of first enrolment: October 2010
• Target sample size: 52
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01319357
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Roland E Schmieder, MD
• Affiliation: University of Erlangen-Nürnberg

Key inclusion & exclusion criteria

Inclusion criteria:

- Type 2 diabetes mellitus defined by fasting glucose =126 mg/dl or HbA1c =6.5% or on
blood glucose lowering medication

- Age of 18 - 75 years

- Male and Female patients are eligible. Females of child bearing potential or within
two years of the menopause are only eligible if pregnancy test at the screening visit
is negative and they use adequate contraceptive precautions during the trial.

- The patient must demonstrate that she/he is able and willing to perform blood glucose
measurements as necessary for Home Blood Glucose Monitoring by herself/himself after
it was demonstrated to her/him.

Exclusion Criteria:

- Any other form of diabetes mellitus than type 2 diabetes mellitus

- Patients with more than on one blood glucose lowering medication or on insulin
therapy

- Last measured HbA1c > 11%

- Blood pressure levels =180/110 mmHg

- Body mass index >50 kg/m²

- Triglyceride levels >1000 mg/dl

- HDL-cholesterol levels <25 mg/dl

- Estimated creatinine clearance < 50 ml/min/1.73m²

- Macroalbuminuria defined by urinary albumine-to-creatinine ratio > 300 mg/g

- Known liver function test >3 times upper limit of normal

- Pregnant or breast-feeding patients

- Current or previous (within 6 months) treatment with an incretin-based therapy such
as DPP 4 inhibitors and/or GLP-1 mimetics

- Any patient currently receiving chronic (>30 consecutive days) treatment with an oral
corticosteroid

- Acute cardiovascular event (including myocardial infarction, unstable angina
pectoris, percutaneous coronary intervention, heart failure, stroke, TIA. PRIND,
intracerebral bleeding) <6 months prior to screening visit (visit 1)

- Diabetic retinopathy

- History of epilepsia or history of seizures

- Patients being treated for severe auto immune disease e.g. lupus

- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
and BMS or representative staff and/or staff at the study site)

- Previous randomisation in the present study

- Participation in another clinical study within 30 days prior to visit 1

- Individuals at risk for poor protocol or medication compliance

- Subject who do not give written consent, that pseudonymous data will be transferred
in line with the duty of documentation and the duty of notification according to § 12
and § 13 GCP-V



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 2

Intervention(s)

Drug: Placebo

Drug: Saxagliptin

Primary Outcome(s)

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)]

Secondary ID(s)

SAXA24011980GLIPTIN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors