Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

Inclusion Criteria

Type 2 diabetes mellitus according to the ADA criteria
HbA1c between 6.5 % and 9.9 %
Treatment with sulfonylurea and/or metformin in a stable dosage within the last 3 months
Age between 40 and 75 years
BMI < 40

Exclusion Criteria

Type 1 diabetes mellitus
Pre-treatment with insulin within the last 6 months prior to screening
Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
Untreated hypertension stage II-III according to WHO criteria
Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
Total cholesterol > 300 mg/dl (anamnestically)
Major micro- or macrovascular complications as judged by the investigator
Tobacco use within the last 6 months prior to screening
Drugs with major impact on endothelial function like nitrates etc.
History of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance
History of hypersensitivity to the study drugs or to drugs with similar chemical structures
History of severe or multiple allergies
Treatment with any other investigational drug within 3 months prior to screening
Progressive fatal disease
History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dL in women and > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
Pregnancy or breast feeding
Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
Lack of compliance or other similar reason that at the discretion of the investigator precludes satisfactory participation in the study
Hypopotassemia (K<3.5 mmol /l)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin VIAject™ (90%)	Insulin VIAject™ (90%)	Single injection
Regular Human Insulin	Regular Human Insulin	Single Injection
Insulin VIAject™ (75%)	Insulin VIAject™ (75%)	Single Injection
Inuslin Lispro (90%)	Insulin Lispro	Single Injection

Primary Outcome Measures

Name	Time	Method
Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro.	0 - 240 minutes

Secondary Outcome Measures

Name	Time	Method
The secondary objectives are to evaluate the postprandial time course of arterial elasticity (pulse wave analysis; PWA), blood glucose, insulin, intact proinsulin, nitrotyrosine, glucagon, ICAM-1, VCAM, E-selectin.	0 - 240 minutes