Diastolic Dysfunction (Diast Dysfkt)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01888796
First received: June 20, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Diabetes Mellitus Type 2 (T2DM),
Left Ventricular Diastolic Dysfunction
Drug: Linagliptin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Linagliptin
Linagliptin 5 mg (tablets) once daily for 6 month
Drug: Linagliptin
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
Drug: placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01888796

Contacts
Contact: Nikolaus Marx, Univ.-Prof. +49 241 80 89301 nmarx@ukaachen.de
Contact: Michael Lehrke, PD Dr. med. +49 241 8089301 mlehrke@ukaachen.de

Locations
Germany
Department of Internal Medicine I, University Hospital Recruiting
Aachen, Germany, 52074
Contact: Nikolaus Marx, Univ.-Prof.    +49 241 80 89301    nmarx@ukaachen.de   
Contact: Angela Sudhoff, M.Sc.    +49 241 80 37429    asudhoff@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Nikolaus Marx, Univ.-Prof. Department of Internal Medicine I, RWTH Aachen University Hospital
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01888796     History of Changes
Other Study ID Numbers: 12-025, 2012-003858-81, EK 113/13
Study First Received: June 20, 2013
Last Updated: June 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
T2DM
diastolic dysfunction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014