A Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT01235039
First received: November 2, 2010
Last updated: October 4, 2011
Last verified: November 2010
  Purpose

The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25 and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7 with those of VIAject®25 and insulin lispro.


Condition Intervention Phase
Diabetes Mellitus
Drug: VIAject®25
Drug: VIAject®7
Drug: Insulin Lispro
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Center, Double Blind, Randomized Crossover Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • Serum insulin concentration [ Time Frame: 0-480 minutes ] [ Designated as safety issue: Yes ]
    Area under the serum insulin concentration curve for the time interval 0-480 min (AUC-INS 0-480) and maximum serum insulin concentration (C-INS max) (VIAject®7and VIAject®25 only)


Secondary Outcome Measures:
  • Serum insulin concentration [ Time Frame: 0-240 minutes ] [ Designated as safety issue: Yes ]
    • AUC-INS: area under the serum insulin concentration curve for the time period 0-240 minutes
    • AUC-INS: area under the serum insulin concentration curve for the time period 0 (VIAject® dosing) to the time when the insulin value returns to baseline

  • Glucose infusion rate [ Time Frame: Between 0-240 minutes and 0-480 minutes ] [ Designated as safety issue: Yes ]
    •AUCGIR: area under the glucose infusion rate curve for the following time periods: 0-240, 0-480 minutes


Enrollment: 43
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A
VIAject®25 for subcutaneous application
Drug: VIAject®25
Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL
Experimental: Formulation B
VIAject®7 for subcutaneous application
Drug: VIAject®7
One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL
Experimental: Formulation C
Insulin Lispro for subcutaneous application
Drug: Insulin Lispro
One vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥19 to ≤65 years
  • Body Mass Index: ≥18 - ≤28 kg/m2
  • Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
  • Insulin antibody less than or equal to 10 µU/mL at screening
  • Non-smoker, defined as no nicotine consumption for at least one year.
  • Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)

Exclusion Criteria:

  • Type 2 Diabetes Mellitus
  • C-peptide value of >1.0 ng/mL
  • HbA1c value of > 10.0%
  • History of hypersensitivity to any of the components in the study medication
  • History of severe or multiple allergies
  • Treatment with any other investigational drug in the last 3 months before study entry
  • Any systemic treatment with drugs known to interfere with glucose metabolism such as systemic corticoids, non-selective beta-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization.
  • Changes (type of drug or dose) in concomitant medication other than insulin or insulin analogues in the last 3 weeks prior to randomization.
  • Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol/acetaminophen is permitted.
  • Progressive disease likely to prove fatal (e.g. malignancies)
  • Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety or protocol compliance
  • Significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
  • Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (serum creatinine values above the upper limit of normal) will not be allowed to enter the trial.
  • Any serious systemic infectious disease during the four weeks prior to the first dose of study drug, as judged by the Investigator.
  • History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose a risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
  • Blood donation within the last 30 days
  • A woman who is lactating
  • Pregnant women or women intending to become pregnant during the study
  • A sexually active woman - not using adequate contraceptive methods (adequate contraceptive measures include: implants, injectables, combined oral contraceptives, hormonal intrauterine device [IUD], sexual abstinence or vasectomized partner)
  • Positive serology for HIV, Hepatitis B or Hepatitis C
  • Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the Investigator
  • 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: NCT01235039

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Biodel
Investigators
Principal Investigator: Tim Heise, M.D Profil Institut für Stoffwechselforschung GmbH
  More Information

No publications provided

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT01235039     History of Changes
Other Study ID Numbers: VIAject -030J
Study First Received: November 2, 2010
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 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014