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Effects of Linagliptin on Renal Endothelium in Type 2 Diabetes
NCT01835678Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2012
- Primary completion
- Mar 2014
- Countries
- 1
- Sponsor
- FAU Erlangen-Nürnberg Medical Faculty
- Modality
- Small Molecules
- Drugs
- linagliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) comparing Linagliptin with Placebo (2 arms). Primary endpoint: Basal production and release of nitric oxide (NO) from renal vasculature at 4 weeks. Started Oct 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Linagliptin
Linagliptin 5 mg/d orally
Placebo
Placebo orally once a day
03
Who it enrols
Patients with Type 2 diabetes without diabetic nephropathy. Excludes patients with UACR > 100 mg/g, eGFR < 45 ml/min/1.73m2, or recent cardiovascular events.
04
Endpoints
Primary
Basal production and release of nitric oxide (NO) from renal vasculature
Secondary
Other renal hemodynamic parameters
Urinary albumin creatinine ratio
Tubular markers (e.g. NGAL)
Markers of oxidative stress (e.g. isoprostanes)
Markers of inflammation (e.g. hsCRP)
Metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol)
Change of renal plasma flow due to L-NMMA-infusion
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