Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Diabetes mellitus type 1
Echocardiography:
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
Primary purpose
Allocation
Interventional model
Masking
8 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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