EUCTR2013-000364-28-DE进行中（未招募）1 期
Effects of Linagliptin on active GLP-1 concentrations in subjects with renal impairment
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed and dated written informed consent obtained before any study-related activities.
- •2. Have Type 2 diabetes mellitus based on the disease diagnostic criteria (WHO)
- •classification on ongoing insulin therapy on a stable regimen of antidiabetic treatment
- •other than metformin , GLP-1 agonists and DPP-4 antagonists for the previous 6 weeks
- •(participants using either of these therapies will be asked to stop their treatment until
- •the end of the study. They will be allowed a wash-out period of 6 weeks before the first
- •GTT will be performed).
- •3. Male or female subjects aged between 18 and 75 years, inclusive.
- •4. Have an HbA1c level between 7.0-9.5 %.
- •5. Medical history without major pathology (with the exception of type 2 diabetes) as judged
- •by the investigator.
- •6. Ability and willingness to abstain from grapefruit juice (and all grapefruit containing
- •products) throughout the study starting 12 hours prior to first study test and from alcohol,
- •methylxanthine-containing beverages or food (coffee, tea, Coke, chocolate, power
- •drinks”), tobacco products and from engaging in strenuous physical activity from 12 hours
- •prior to each admission until discharge from the unit.
- •7.For female patients of childbearing potential: Use of acceptable method of contraception
- •(Pearl-Index <1). Acceptable methods of birth control include tubal ligation, transdermal
- •patch, intra uterine devices/systems (IUD/IUSs), oral, implantable or injectable
- •contraceptives, sexual abstinence, double barrier method and vasectomised partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary
- •forms of diabetes such as due to pancreatitis.
- •2. Current or previous treatment (less than 6 weeks) with metformin, DPP-4 inhibitors or
- •GLP-1 analogues.
- •3. Have any contraindications, known allergy, or hypersensitivity to linagliptin.
- •4. Have participated in an interventional medical, surgical, or pharmaceutical study within
- •the last three months prior to entry into the study.
- •5. Women of child-bearing age who are pregnant, or plan a pregnancy.
- •6. Subjects on systemic glucocorticoid treatment (except topic or inhalative preparations) within the last 3 months prior to screening.
- •7. Subjects that underwent surgery of the upper gastrointestinal tract.
- •8. Subjects with any severe medical or surgical history of conditions likely to confound
- •study assessments or study endpoints, for example but not limited to
- •haemoglobinopathies, inflammatory bowel disease, cystic fibrosis, bariatric surgery
- •and/or any surgery shortening the intestine, history of galactose intolerance, lactose- or
- •glucose-galactose-malabsorption.
- •9. Subjects with a suspicion for medullar thyroid cancer or a multiple endocrine neoplasia
- •will undergo a calcitonine measurement.
- •10. Subjects with a personal or family history of medullar thyroid cancer or a multiple
- •endocrine neoplasia.
- •11. Serious and/or unstable coronary heart disease (unstable angina, myocardial infarction
- •within the preceding 6 months), congestive heart failure of New York Heart Association
- •Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary
- •physical activity results in fatigue, palpitation, or dyspnoea), second/third degree heart
- •block, superior vena cava syndrome, uncontrolled hypertension, history of congenital QTsyndrome
- •within family, history of stroke (within the preceding 6 months) or serious
- •peripheral vascular disease.
- •12. Marked diabetic complications with the exception of peripheral neuropathy: severe autonomic neuropathy including gastroparesis;
- •proliferative retinopathy as judged by the Investigator.
- •13. Clinically significant vital signs including known bradycardia with pulse rate < 50/min or
- •12-lead ECG findings including pre-treatment mean QTc > 450 msec for males or QTc >
- •470 msec for women (if first ECG shows increased values, 2 further ECGs will be
- •performed at least 2 minutes apart and values will be averaged).
- •14. Clinically significant abnormal haematology, biochemistry, or coagulation screening tests,
- •as judged by the Investigator.
- •15. Clinical or laboratory evidence of hepatic dysfunction or disease; laboratory evidence
- •defined as any of the following parameters: ?-GT, ALT, or AST > 3x ULN.
- •16. Chronic pancreatitis.
- •17. Uncontrolled high blood pressure (DBP > 95 mmHg and/or SBP > 160 mmHg), unless
- •clearly documented to be white-coat hypertension.
- •18. History of any psychiatric condition that might impair the subject’s ability to understand
- •or to comply with the requirements of the study or to provide informed consent.
- •19. History of relevant drug and/or food allergies or a history of severe anaphylactic reaction.
- •20. Not willing to abstain from any consume of tobacco containing products 12 hours prior to
- •each admission until discharge.
- •21. Currently active or history of alcohol abuse (defined as an intake of more than 24 units of
- •alcohol per week; one unit of alcohol equals approximately 250 mL of beer, 100 mL o
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