Effect of Prandial Treatment with Insulin Glulisine compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients - Insulin glulisine and postprandial vascular functio

• Conditions: Diabetes mellitus Type 2; MedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2006-005127-42-DE
• Lead Sponsor: Institut für Klinische Forschung und Entwicklung (ikfe) GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-19
• 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 ADA criteria
2. HbA1c between 6.5 % and 9.9 %
3. Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months
4. Age between 40 and 70 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. Treatment with glitazones within the last 6 months prior to screening
4. Pre-Treatment with PPARy-agonists, glinids or glucosidase inhibitors within the last 4 weeks prior to screening
5. Untreated hypertension stage II-III according to WHO criteria
6. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
7. Total Cholesterol > 300 mg/dl (anamnestically)
8. Hypocalemia (K < 3.5 mmol/l)
9. Major micro- or macrovascular complications as judged by the investigator
10. Tobacco use within the last 12 months prior to screening
11. Drugs with major impact on endothelial function like nitrates etc.
12. History of drug or alcohol abuse within the last five years prior to screening
13. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
14. History of severe or multiple allergies
15. Treatment with any other investigational drug within 3 months prior to screening
16. Progressive fatal disease
17. 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
18. Pregnancy or breast feeding
19. Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
20. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study

Study & Design

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