Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in left ventricular diastolic function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Linagliptin
Linagliptin 5 mg (tablets) once daily for 6 month
干预措施: Linagliptin (Drug)
Placebo
Placebo (tablets) once daily for 6 month
干预措施: placebo (Drug)
结局指标
主要结局
Change in left ventricular diastolic function
时间窗: 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
次要结局
- Change in serum NT-pro BNP levels(baseline and 6 months)