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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.

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ClinicalTrials.gov Identifier: NCT00849576
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Biodel

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT00849576     History of Changes
Other Study ID Numbers: VIAject™-15J
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015

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