Patients with type 2 diabetes mellitus below 70 years of age and without a history of cardiovascular disease. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: NovoRapid®
Product Name: NovoRapid®
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Sponsors
Karolinska Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if platelet activation following a carbohydrate rich meal is related to the post-prandial hyperglycemia, and thus can be attenuated by premeal insulin treatment in patients with T2DM. ;Secondary Objective: To elucidate if reduction of postprandial glucose levels by insulin aspart treatment reduces platelet activation and platelet-leukocyte conjugation, as assessed by other platelet-related parameters (see below), in patients with T2DM. To elucidate if short-term lowering of blood glucose by insulin infusion (pretreatment standardization of blood glucose) reduces platelet activity in patients with T2DM. To elucidate relationships between inflammatory activity and postprandial platelet activation and treatment effects. Possibilities of evaluating oxidative stress in a similar manner will be considered. ;Primary end point(s): Treatment effect on postprandial platelet activation. Co-primary response variables are: the thromboxane A2 analogue U46619 stimulated platelet P-selectin expression; U46619 stimulated platelet-leukocyte aggregation; circulating platelet-platelet aggregates; and circulating platelet-monocyte aggregates. | — |
Countries
Sweden
Outcome results
None listed