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

Primary Purpose

Diabetes Mellitus Type 2 (T2DM), Left Ventricular Diastolic Dysfunction

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Linagliptin
placebo
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 (T2DM) focused on measuring T2DM, diastolic dysfunction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine I, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Linagliptin

Placebo

Arm Description

Linagliptin 5 mg (tablets) once daily for 6 month

Placebo (tablets) once daily for 6 month

Outcomes

Primary Outcome Measures

Change in left ventricular diastolic function
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
Change in serum NT-pro BNP levels

Full Information

First Posted
June 20, 2013
Last Updated
April 10, 2017
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01888796
Brief Title
Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
Acronym
Diast Dysfkt
Official Title
Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
bad recruitment of suitable participants, just 8 patients in one year
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 (T2DM), Left Ventricular Diastolic Dysfunction
Keywords
T2DM, diastolic dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linagliptin
Arm Type
Active Comparator
Arm Description
Linagliptin 5 mg (tablets) once daily for 6 month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (tablets) once daily for 6 month
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in left ventricular diastolic function
Description
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
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in serum NT-pro BNP levels
Description
Change in serum NT-pro BNP levels
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus Type 2 Age > 50 years HbA1c > 7% Left ventricular diastolic dysfunction determined by echocardiography as average E/é ≥13 or average E/é≥8 and LA volume ≥34ml/m2 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). Indication to increase anti-diabetic medication as judged by the investigator Written informed consent prior to study participation Exclusion Criteria: Diabetes mellitus type 1 Echocardiography: decreased left ventricular systolic function, ejection fraction (EF) <45% regional wall motion abnormalities hypertrophic cardiomyopathy (septum >15mm) severe valvular dysfunction Uncontrolled hypertension Atrial fibrillation Obstructive sleep apnea syndrome Use of DPP-4 Inhibitor (Dipeptidyl-peptidase IV Inhibitor), GLP 1 agonists, Thiazolindinedione Kidney disease CKD 4 and more (GFR < 30 ml/min/1.73) Liver disease (ALT or AST > 3 times the upper limit of norm) or known liver cirrhosis Active malignant disease HbA1c > 8.5% Recent (<3 months) clinically significant coronary or cerebral vascular event 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. Lactating females 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. The subject received an investigational drug within 30 days prior to inclusion into this study 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 The subject is unwilling or unable to follow the procedures outlined in the protocol The subject is mentally or legally incapacitated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaus Marx, Univ.-Prof.
Organizational Affiliation
Department of Internal Medicine I, RWTH Aachen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine I, University Hospital
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus

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