Effects of insulin treatment on postprandial platelet activation in patients with NIDDM: a placebo-controlled dose-response study with insulin aspart (Novorapid®)
- Conditions
- Patients with type 2 diabetes mellitus below 70 years of age and without a history of cardiovascular disease.MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2006-007031-27-SE
- Lead Sponsor
- Karolinska Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method