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Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus (Diast Dysfkt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):

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
Diabetes Mellitus Type 2 (T2DM) Left Ventricular Diastolic Dysfunction Drug: Linagliptin Drug: placebo 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  (Clinical Trial)
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 : September 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in serum NT-pro BNP levels [ Time Frame: baseline and 6 months ]
    Change in serum NT-pro BNP levels


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
Germany
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
More Information

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01888796     History of Changes
Other Study ID Numbers: 12-025
2012-003858-81 ( EudraCT Number )
EK 113/13 ( Other Identifier: Ethics Committee University Hospital Aachen )
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: February 2015

Keywords provided by RWTH Aachen University:
T2DM
diastolic dysfunction

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