A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT01000922
First received: October 21, 2009
Last updated: October 4, 2011
Last verified: August 2010
  Purpose

Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.


Condition Intervention Phase
Diabetes Mellitus
Drug: Regular Human Insulin
Drug: Lispro
Drug: VIAject
Drug: VIAject 50%
Drug: VIAject/Insulin Glargine
Drug: Insulin Glargine/VIAject
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center, Randomized, Open-Label, Crossover Study, Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro Either in Combination With a Basal Insulin Infusion or With Insulin Glargine Relative to a Standardized Meal in Patients With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regular Human Insulin
Single injection
Drug: Regular Human Insulin
Individual dose of RHI administered subcutaneously
Experimental: Lispro
Single injection
Drug: Lispro
Individual dose of lispro administered subcutaneously
Experimental: VIAject
Single injection
Drug: VIAject
Individual dose of VIAject administered subcutaneously
Experimental: VIAject 50%
Single injection
Drug: VIAject 50%
Individual dose of VIAject 50% administered subcutaneously
Experimental: VIAject/Insulin glargine
Single injection
Drug: VIAject/Insulin Glargine
VIAject mixed wiht insulin glargine and administered subcutaneously
Experimental: Insulin Glargine/VIAject
Single injection
Drug: Insulin Glargine/VIAject
Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Established diagnosis of type 1 diabetes for not less than 5 years
  2. HbA1c values of not more than 9%
  3. Age: 19 to 70 years
  4. Sex: Male or Female
  5. Body Mass Index: 18 - 28 kg/m2
  6. Informed consent must be obtained in writing for all volunteers.

Exclusion Criteria:

  1. Type 2 Diabetes mellitus.
  2. History of hypersensitivity to any of the components in the study medication.
  3. History of severe or multiple allergies.
  4. Treatment with any other investigational drug in the last 1 month before study entry.
  5. Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
  6. Progressive disease likely to prove fatal (e.g. malignancies).
  7. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
  8. Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
  9. Blood donation within the last 30 days.
  10. A women who is lactating.
  11. Pregnant women or women intending to become pregnant during the study.
  12. A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
  13. Positive Serology for HIV, Hepatitis B or Hepatitis C.
  14. Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
  15. A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.
  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: NCT01000922

Locations
United States, California
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Biodel
Investigators
Principal Investigator: Marcus Hompesch, MD Profil Institute for Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT01000922     History of Changes
Other Study ID Numbers: VIAJECT™-010JM
Study First Received: October 21, 2009
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Biodel:
Mealtime Insulin
Rapid acting insulin
Ultra fast VIAject
prandial insulin

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

ClinicalTrials.gov processed this record on October 23, 2014