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

NCT01235039 | Completed Phase 1

• 1 other identifier: VIAject -030J
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Serum insulin concentration

  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)

  0-480 minutes

Secondary Outcomes (2)

• Serum insulin concentration

  0-240 minutes

• Glucose infusion rate

  Between 0-240 minutes and 0-480 minutes

Study Arms (3)

Formulation A

EXPERIMENTAL

VIAject®25 for subcutaneous application

Drug: VIAject®25

Formulation B

EXPERIMENTAL

VIAject®7 for subcutaneous application

Drug: VIAject®7

Formulation C

EXPERIMENTAL

Insulin Lispro for subcutaneous application

Drug: Insulin Lispro

Interventions

VIAject®25 DRUG

Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL

Formulation A

VIAject®7 DRUG

One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL

Formulation B

Insulin Lispro DRUG

One vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL

Formulation C

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biodel: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tim Heise, M.D

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 5, 2010
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

DE (1)