Status:
TERMINATED
Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
RWTH Aachen University
Conditions:
Diabetes Mellitus Type 2 (T2DM)
Left Ventricular Diastolic Dysfunction
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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. Furthe...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01888796
Start Date
September 1 2013
End Date
December 1 2014
Last Update
April 12 2017
Active Locations (1)
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1
Department of Internal Medicine I, University Hospital
Aachen, Germany, 52074