Effects of Linagliptin on Renal Endothelium Function in Patients With Type 2 Diabetes.

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Apr 18, 2013

Keywords

ClinConnect Summary

Diabetes mellitus is a metabolic disease with a growing prevalence worldwide, affecting 171 million people in 2000 and an expected 366 million people in 2030 (1) and therefore diabetic nephropathy is rapidly increasing in the Western hemisphere and represents in up to 50 % the cause of end stage renal disease. Hence, early intervention is desirable to prevent any damage to the kidneys. In the early stage of diabetic nephropathy, endothelium dysfunction is a key pathogenetic process as indicated by increased leakage of albumin through the glomerular barrier (2).

Hence, improvement of endoth...

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Eligibility criteria

• Inclusion Criteria:
• • Female and male patients aged between 18 and 70 years
• • Type 2 diabetes without diabetic nephropathy (definition see exclusion criteria)
• Exclusion Criteria:
• • Any other form of diabetes mellitus than type 2 diabetes mellitus
• • Use of insulin, glitazone or gliptins within the past 3 months
• • Any other oral antidiabetic drug that can not be discontinued for the study period.
• • Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
• • Urinary albumin excretion (UACR) \> 100 mg/g (early morning spot urine)
• • eGFR \<45 ml/min/1.73m² (MDRD Formula)
• • Uncontrolled arterial hypertension (RR ≥180/ ≥110mmHg)
• • HbA1c ≥ 10%
• • Fasting plasma glucose ≥ 240 mg/dl
• • Body mass index ≥ 40 kg/m²
• • Triglyceride levels ≥ 1000 mg/dl
• • HDL-cholesterol levels \<25 mg/dl
• • Overt congestive heart failure (CHF) or history of CHF
• • Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of study drugs
• • Significant laboratory abnormalities such as SGOT or SGPT levels more than 3 x above the upper limit of normal range, serum creatinine \> 2mg/dl
• • Drug or alcohol abuses
• • Pregnant or breast-feeding patients
• • Any patient currently receiving chronic (\>30 consecutive days) treatment with an oral corticosteroid
• • Patients being treated for severe auto immune disease e.g. lupus
• • 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