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Diast Dysfkt: Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus

Sponsor
RWTH Aachen University (Other)
Overall Status
Terminated
CT.gov ID
NCT01888796
Collaborator
(none)
8
Enrollment
1
Location
2
Arms
15
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Linagliptin

Linagliptin 5 mg (tablets) once daily for 6 month

Drug: Linagliptin
Other Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Change in left ventricular diastolic function [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

    Secondary Outcome Measures

    1. Change in serum NT-pro BNP levels [baseline and 6 months]

      Change in serum NT-pro BNP levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Uncontrolled hypertension

    2. Atrial fibrillation

    3. Obstructive sleep apnea syndrome

    4. Use of DPP-4 Inhibitor (Dipeptidyl-peptidase IV Inhibitor), GLP 1 agonists, Thiazolindinedione

    5. Kidney disease CKD 4 and more (GFR < 30 ml/min/1.73)

    6. Liver disease (ALT or AST > 3 times the upper limit of norm) or known liver cirrhosis

    7. Active malignant disease

    8. HbA1c > 8.5%

    9. Recent (<3 months) clinically significant coronary or cerebral vascular event

    10. 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.

    11. Lactating females

    12. 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.

    13. The subject received an investigational drug within 30 days prior to inclusion into this study

    14. 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

    15. The subject is unwilling or unable to follow the procedures outlined in the protocol

    16. The subject is mentally or legally incapacitated

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Internal Medicine I, University Hospital Aachen Germany 52074

    Sponsors and Collaborators

    • RWTH Aachen University

    Investigators

    • Principal Investigator: Nikolaus Marx, Univ.-Prof., Department of Internal Medicine I, RWTH Aachen University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RWTH Aachen University
    ClinicalTrials.gov Identifier:
    NCT01888796
    Other Study ID Numbers:
    • 12-025
    • 2012-003858-81
    • EK 113/13
    First Posted:
    Jun 28, 2013
    Last Update Posted:
    Apr 12, 2017
    Last Verified:
    Feb 1, 2015
    Keywords provided by RWTH Aachen University
    T2DM
    diastolic dysfunction
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Linagliptin

    Study Results

    No Results Posted as of Apr 12, 2017