Effects of insulin treatment on postprandial platelet activation in patients with NIDDM: a placebo-controlled dose-response study with insulin aspart (Novorapid®)

Karolinska Institute0 个研究点目标入组 20 人开始时间: 2007年2月23日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•Patients with T2DM below 70 years of age and with T2DM without a history of cardiovascular disease. The patients may be treated with metformin and/or insulin. Metformin treatment should be kept constant during the study. Glitazone or sulphonylurea treatment is not allowed during the study. Previous insulin treatment may be ”basal” insulin and/or meal insulin from any manufacturer.
•HbA1c 7-9 % (Mono-S method).
•Antecubital forearm veins allowing technically good sampling for platelet studies.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Acute or chronic kidney disease (S-creatinine should be within the reference interval)
•Acute or chronic liver disease (PK should be within the reference interval and ASAT and/or ALAT =2 times the upper reference value).
•Contraindication(s) to insulin treatment.
•Need for treatment with anticoagulants or acetylsalicylic acid.
•Thrombocytopenia (platelet count <150 x 109/L)
•Anticipated need for alteration of concomitant drug therapy during the course of the study.
•Enrollment in another clinical study.

发起方

Karolinska Institute