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.

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849576
• Other study ID #: VIAject™-15J
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2009
• Last updated: July 30, 2015
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: July 2015
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

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 reason that at the discretion of the investigator precludes satisfactory participation in the study

19. Hypopotassemia (K<3.5 mmol /l)

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Regular Human Insulin
0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal.
• Insulin Lispro
90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal.
• Insulin VIAject™ (75%)
75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
• Insulin VIAject™ (90%)
90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal

Locations

Country	Name	City	State
Germany	IKFE	Parcusstrasse 8	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro.		0 - 240 minutes	No
Secondary	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	No