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Study details: Ott et al. 2013
This was a randomised, double-blind, placebo-controlled investigator sponsored cross-over trial. The aim was to analyse the impact of saxagliptin on early microvascular changes due to type 2 diabetes by noninvasively measuring the retinal circulation, documenting haemodynamic changes and assessing early vascular remodeling.
Patients of either gender and age between 18 and 75 years were eligible for inclusion into the study given they were diagnosed with T2D (defined by fasting glucose ~7.0 mmol/L or HbA1c ~ 6.5% (48 mmol/mol) or receiving anti-diabetic pharmacotherapy). Patients with micro- or macrovascular complications such as diabetic retinopathy, macroalbuminuria, an acute cardiovascular event, unstable angina or stroke within 6 months prior to enrolment were excluded.
Patients (n=42) were randomly assigned to either 5 mg of saxagliptin once daily or matching placebo. At 6 weeks patients' treatment was switched (cross-over) and treatment continued for another 6 weeks without a washout between treatment phases.The total treatment duration was 12 weeks.
Retinal arteriolar structure and retinal capillary flow (RCF) at baseline and during flicker-light exposure was assessed by scanning laser Doppler flowmetry. Central hemodynamies were assessed by pulse wave analysis.