Status:
COMPLETED
Effects of Linagliptin on Renal Endothelium Function in Patients With Type 2 Diabetes.
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Type 2-diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Female and male patients aged between 18 and 70 years
- Type 2 diabetes without diabetic nephropathy (definition see exclusion criteria)
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01835678
Start Date
October 1 2012
End Date
April 1 2014
Last Update
January 12 2018
Active Locations (2)
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1
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, Germany, 91054
2
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
Nuremberg, Germany, 90471