Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin.

The secondary objectives are to evaluate the postprandial time course of the following efficacy parameters after injection of insulin glulisine compared with regular insulin on

• Blood Glucose

• Insulin

• Intact proinsulin

• Asymmetric dimethylarginine (ADMA)

• Metal matrix proteasis (MMP-9)

• Oxidative status (per ox)

• Interleukin 18 (IL-18)

• Free fatty acids (FFA)

• Oxidised LDL (ox-LDL)

• Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)

• Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IKFE Institute for Clinical Research and Development
• Treatments: Insulin; Insulin glulisine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Type 2 Diabetes mellitus according to the 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

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, glinides 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. Hypokalemia (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, > 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