Effect of prandial treatment with insulin VIAjectTM compared to regular human insulin and insulin lispro on postprandial endothelial function and microvascular stress in type 2 diabetic patients

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus; Type 2 Diabetes Mellitus

• Registration Number: EUCTR2008-001184-11-DE
• Lead Sponsor: Biodel Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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

1. Type 1 diabetes mellitus
2. Pre-treatment with insulin within the last 6 months prior to screening
3. Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
4. Untreated hypertension stage II-III according to WHO criteria
5. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
6. Total cholesterol > 300 mg/dl (anamnestically)
7. Major micro- or macrovascular complications as judged by the investigator
8. Tobacco use within the last 6 months prior to screening
9. Drugs with major impact on endothelial function like nitrates etc.
10. History of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance
11. History of hypersensitivity to the study drugs or to drugs with similar chemical structures
12. History of severe or multiple allergies
13. Treatment with any other investigational drug within 3 months prior to screening
14. Progressive fatal disease
15. 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
16. Pregnancy or breast feeding
17. 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
18. Lack of compliance or other similar reasonthat at the discretion of the investigator precludes satisfactory participation in the study
19. Hypopotassemia (K<3.5 mmol /l)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the postprandial time course of ADMA after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro. ;Secondary Objective: 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, mRNA expression of mitogen-activated protein kinases (MAPK), mRNA expression of nitric oxide synthetase (NOS), free fatty acids (FFA), high-sensitive C-reactive peptide (hsCRP), skin microvascular blood flow, and microvascular Hb oxygenation.;Primary end point(s): The postprandial time course of ADMA after injection of insulin VIAjectTM