Back to resultsDiastolic 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
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 (T2DM) focused on measuring T2DM, diastolic dysfunction
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
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
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
Learn more about this trial
Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
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