Effects of ARA 290, a non-hematopoietic erythropoietin analog, on glucose tolerance, insulin secretion, insulin sensitivity and long-term glucose control in individuals with prediabetes and/or drug-naive type 2 diabetes; a phase II study. - ARA290inT2D

Karolinska University Hospital Solna0 个研究点目标入组 12 人开始时间: 2013年7月9日最近更新: 2020年6月2日

适应症

试验速览

暂无简介。

•a.Informed consent obtained prior to any trial-related activities
•b.Meeting criteria for impaired fasting glucose (IFG), impaired glucose tolerance (IGT), IGF+IFG, or type 2 diabetes at the screening OGTT. IFG = fasting P-glucose 5.6-6.9 mmol/l; IGT = 2 hr P-glucose in OGTT 7.8-11.0 mmol/l; diabetes = fasting P-glucose = 7.0 mmol/l and/or 2 hr P-glucose = 11.1 mmol/l.
•c.Age 40-75 years, of both sexes, however women only above 50 year and in menopause.
•d.BMI (body mass index) = 35 kg/m2.
•e.Fasting P-glucose = 9 mmol/l.
•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 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a.Anticipated change in concomitant medication that may interfere with blood glucose homeostasis, such as systemic glucocorticoids, non-selective beta blockers and anabolic steroids.
•b.Anti-diabetic (anti-hyperglycemic) medication of any kind.
•c.Impaired renal function, defined as S-creatinine = 125 umol/l for men and = 115 umol/l for women.
•d.Impaired hepatic function defined as plasma alanin aminotransferase (P-ALT) = three times the upper reference limit.
•e.Cardiac disease defined as unstable angina pectoris, or myocardial infarction within the last 6 months, or congestive heart failure NYHA class III or IV.
•f.Cerebral stroke within the last 6 months.
•g.Uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg).
•h.Cancer, diagnosed and/or treated within the last 5 years.
•i.Females of childbearing potential.
•j.Known or suspected abuse of alcohol or narcotic drugs.
•k. Patients should not have received a vaccination or immunization within the month peior screening.
•l. The use of Anti-TNF therapy or other biological anti-inflammatory agents administered within 3 months to screening is not allowed.
•m. The use of erythropoiesis stimulating agents within the two months prior to screening or during the trial is not allowed.

发起方

Karolinska University Hospital Solna