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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT00849576
First received: February 20, 2009
Last updated: October 4, 2011
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Regular Human Insulin
Drug: Insulin Lispro
Drug: Insulin VIAject™ (75%)
Drug: Insulin VIAject™ (90%)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro. [ Time Frame: 0 - 240 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 0 - 240 minutes ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849576

Locations
Germany
IKFE
Parcusstrasse 8, Mainz, Germany, 55116
Sponsors and Collaborators
Biodel
Investigators
Principal Investigator: Thomas Forst, MD IKFE Institute for Clinical Research and Development
  More Information

No publications provided

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT00849576     History of Changes
Other Study ID Numbers: VIAject™-15J
Study First Received: February 20, 2009
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Lispro
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014