Diastolic Dysfunction (Diast Dysfkt)

This study is currently recruiting participants.
Verified October 2013 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01888796
First received: June 20, 2013
Last updated: October 28, 2013
Last verified: October 2013

June 20, 2013
October 28, 2013
September 2013
April 2015   (final data collection date for primary outcome measure)
Change in left ventricular diastolic function [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01888796 on ClinicalTrials.gov Archive Site
Change in serum NT-pro BNP levels [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
Change in serum NT-pro BNP levels
Same as current
Not Provided
Not Provided
 
Diastolic Dysfunction
Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus

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.

Treatment:

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus Type 2 (T2DM),
  • Left Ventricular Diastolic Dysfunction
  • Drug: Linagliptin
    Other Name: Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
  • Drug: placebo
  • Active Comparator: Linagliptin
    Linagliptin 5 mg (tablets) once daily for 6 month
    Intervention: Drug: Linagliptin
  • Placebo Comparator: Placebo
    Placebo (tablets) once daily for 6 month
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diabetes mellitus Type 2
  2. Age > 50 years
  3. HbA1c > 7%
  4. Left ventricular diastolic dysfunction determined by echocardiography as average E/é ≥13 or average E/é≥8 and LA volume ≥34ml/m2
  5. Stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist).
  6. Indication to increase anti-diabetic medication as judged by the investigator
  7. Written informed consent prior to study participation

Exclusion Criteria:

  1. Diabetes mellitus type 1
  2. Echocardiography:

    • decreased left ventricular systolic function, ejection fraction (EF) <45%
    • regional wall motion abnormalities
    • hypertrophic cardiomyopathy (septum >15mm)
    • severe valvular dysfunction
  3. Uncontrolled hypertension
  4. Atrial fibrillation
  5. Obstructive sleep apnea syndrome
  6. Use of DPP-4 Inhibitor (Dipeptidyl-peptidase IV Inhibitor), GLP 1 agonists, Thiazolindinedione
  7. Kidney disease CKD 4 and more (GFR < 30 ml/min/1.73)
  8. Liver disease (ALT or AST > 3 times the upper limit of norm) or known liver cirrhosis
  9. Active malignant disease
  10. HbA1c > 8.5%
  11. Recent (<3 months) clinically significant coronary or cerebral vascular event
  12. Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
  13. Lactating females
  14. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
  15. The subject received an investigational drug within 30 days prior to inclusion into this study
  16. The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
  17. The subject is unwilling or unable to follow the procedures outlined in the protocol
  18. The subject is mentally or legally incapacitated
Both
50 Years and older
No
Contact: Nikolaus Marx, Univ.-Prof. +49 241 80 89301 nmarx@ukaachen.de
Contact: Michael Lehrke, PD Dr. med. +49 241 8089301 mlehrke@ukaachen.de
Germany
 
NCT01888796
12-025, 2012-003858-81, EK 113/13
Yes
RWTH Aachen University
RWTH Aachen University
Not Provided
Principal Investigator: Nikolaus Marx, Univ.-Prof. Department of Internal Medicine I, RWTH Aachen University Hospital
RWTH Aachen University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP