Type 2 Diabetes Clinical Trial
Official title:
Effects of Dapagliflozin Treatment on Urinary Proteomic Patterns in Patients With Type 2 Diabetes
Background: SGLT2 inhibitors are the first antiglycaemic drugs with a direct renal action. A
part from reducing blood glucose, systemic blood pressure and albuminuria are decreased,
while natriuresis is increased.
Previous research into urinary peptide patterns (proteomics) has revealed that patients in
risk of progressive renal disease display a "risk peptide pattern" in their urine, ahead of
decline in renal function. Furthermore a urinary proteome pattern is related to CVD risk.
The long-term impact of dapagliflozin (dapa) treatment on renal parameters is unknown, but
long term randomized trials are ongoing. By investigating the impact of dapa treatment on
this peptide pattern, it will be determined whether this intervention can improve the urinary
proteomic peptide pattern. In addition new knowledge regarding renal processes that the
treatment influences is sought.
The impact of treatment of urinary and tubular markers of oxidative stress and function
(metabolomics) will be assessed. These markers are thought to represent one of several
deleterious pathways involved in the pathology of diabetic renal disease, and here the impact
dapa treatment will be investigated. Improvement of these markers of oxidative stress may
indicate long-term benefit.
Objective: The primary objective is to assess the impact of three months of treatment with
dapa 10 mg once daily or placebo on renal proteomics pattern and other risk markers of
diabetic comorbidity.
Design: Double blinded, randomized, placebo-controlled crossover, single center study.
Treatment period: 2 x 12 weeks.
Patient population: 40 patients with type 2 diabetes recruited from Steno Diabetes Center in
accordance with the study in- and exclusion criteria.
Intervention: Dapa 10 mg daily vs. placebo. Endpoints: Primary outcome: To evaluate the
effect of dapa treatment on urinary proteomic patterns in patients with type 2 diabetes,
microalbuminuria and eGFR equal to or above 45 ml/min/1.73m2.
Secondary endpoints are the effect of the intervention on other markers for tubular function,
inflammation, endothelial dysfunction, microcirculation, kidney function, albuminuria,
vasoactive hormones in plasma, and effect on global longitudinal strain as measured by
echocardiography.
Timeframe: Randomisation planned from June 2015, inclusion over the following 9 months. Last
patient is expected to be completed October 2016. Data analysis completed December 2016,
presentation autumn 2017 and publication early 2018.
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