Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus (Diast Dysfkt)
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|ClinicalTrials.gov Identifier: NCT01888796|
Recruitment Status : Terminated (bad recruitment of suitable participants, just 8 patients in one year)
First Posted : June 28, 2013
Last Update Posted : April 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2 (T2DM) Left Ventricular Diastolic Dysfunction||Drug: Linagliptin Drug: placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|