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.

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Regular Human Insulin; Drug: Insulin Lispro; Drug: Insulin VIAject™ (75%); Drug: Insulin VIAject™ (90%)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Mainz
    • Parcusstrasse 8, Mainz, Germany, 55116
      • Ikfe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular Human Insulin; Single Injection	Drug: Regular Human Insulin; 0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal.
Active Comparator: Inuslin Lispro (90%); Single Injection	Drug: Insulin Lispro; 90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal.
Experimental: Insulin VIAject™ (75%); Single Injection	Drug: Insulin VIAject™ (75%); 75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
Experimental: Insulin VIAject™ (90%); Single injection	Drug: Insulin VIAject™ (90%); 90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biodel
• Investigators: Principal Investigator: Thomas Forst, MD, IKFE Institute for Clinical Research and Development

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: February 20, 2009
• First Submitted That Met QC Criteria: February 23, 2009
• First Posted (Estimate): February 24, 2009

Study Record Updates

• Last Update Posted (Estimate): August 3, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Lispro
• Other Study ID Numbers: VIAject™-15J