Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus (Diast Dysfkt)
Examination of the effect of Linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography.
Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be investigated.
|Diabetes Mellitus Type 2 (T2DM) Left Ventricular Diastolic Dysfunction||Drug: Linagliptin Drug: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
|Official Title:||Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus|
- Change in left ventricular diastolic function [ Time Frame: baseline and 6 months ]Change in left ventricular diastolic function between baseline and after 6 month as determined by 2D and novel 3D parameter global Strain Rate E Change in left ventricular diastolic function between baseline and after 6 month as determined by standardized parameter E/é and left atrial (LA) volume
- Change in serum NT-pro BNP levels [ Time Frame: baseline and 6 months ]Change in serum NT-pro BNP levels
|Study Start Date:||September 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Linagliptin
Linagliptin 5 mg (tablets) once daily for 6 month
Other Name: Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
Placebo Comparator: Placebo
Placebo (tablets) once daily for 6 month
The Patients will receive Linagliptin 5 mg QD or placebo for a period of 6 months.
The echocardiography and 24h RR measurement will be performed at baseline and 6 months after initiation of the therapy.
The blood chemistry (Glucose, HbA1c, BNP) will be evaluated at baseline as well as 3 and 6 months after initiation of the therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888796
|Department of Internal Medicine I, University Hospital|
|Aachen, Germany, 52074|
|Principal Investigator:||Nikolaus Marx, Univ.-Prof.||Department of Internal Medicine I, RWTH Aachen University Hospital|