An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Biodel
ClinicalTrials.gov Identifier:
NCT00542724
First received: October 5, 2007
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human insulin.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: VIAject™
Drug: Regular Human Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • Change in HbA1c

Enrollment: 462
Study Start Date: September 2006
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
VIAject™
Drug: VIAject™
Dosage as individually required
Active Comparator: B
Regular Human Insulin
Drug: Regular Human Insulin
Dosage as individually required

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female patients with type 1 diabetes must present with the following:

  • Established diagnosis of type 1 diabetes for more than 1 year.
  • HbA1c values of not more than 10.5%.
  • Three months on a stable insulin regimen that meets the current standard of care and that includes at least two daily insulin injections.
  • Age: 18 to 70 years.
  • Body Mass Index: 18 - 38 Kg/m2.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

  • Type 2 diabetes mellitus as determined by the investigator.
  • History of frequent severe hypoglycemia within the prior six months.
  • C-peptide > 1.0 ng/ml unless there is a documented history of ketoacidosis or a documented history of a positive anti GAD test.
  • History of known hypersensitivity to any of the components in the study medication.
  • History of severe or multiple allergies.
  • Treatment with investigational diabetes drug in the last 3 months or treatment with any other investigational drug in the last 30 days before study entry.
  • Current short-term treatment with systemic oral, injected, or inhaled corticosteroids. (inhaled corticosteroids may be allowed when the treatment is long-term).
  • Progressive disease likely to prove fatal.
  • History of malignancy within the past 5 years except for basal cell epithelioma.
  • Known significant hepatic disease or serum AST or ALT values ≥ 3 X upper limit of normal or bilirubin levels ≥ 1.5 X upper limit of normal.
  • Severe complications of diabetes mellitus including a history or finding of Stage III or IV diabetic retinopathy, proteinuria > 2+ by urine dipstick, serum creatinine of >1.8 mg/dl for males or >1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease which has resulted in an amputation, chronic foot ulcers claudication or absent pedal pulses.
  • Known history of autonomic neuropathy.
  • History of moderate to severe ketoacidosis within the 3 months preceding screening for the study.
  • Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair patient safety or protocol compliance.
  • Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator.
  • Blood donation within the last 30 days.
  • A woman who is breast feeding.
  • Pregnant women or women intending to become pregnant during the study.
  • A sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy.
  • Abnormal ECG, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the patient in the study to be inappropriate or unsafe.
  • A history of lack of compliance with medical instructions, recent drug or alcohol abuse, or other reasons which, in the opinion of the investigator, render the participation of the patient in the study to be inappropriate or unsafe.
  • Current significant diseases of the adrenal gland, pituitary gland or thyroid at the discretion of the investigator.
  • Glomerular Filtration Rate < 40 ml/min.
  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: NCT00542724

Sponsors and Collaborators
Biodel
Investigators
Principal Investigator: David C Klonoff, M.D., F.A.C.P. University of Miami
  More Information

Additional Information:
No publications provided

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT00542724     History of Changes
Other Study ID Numbers: VIAject™-06J
Study First Received: October 5, 2007
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India

Keywords provided by Biodel:
Insulin
Diabetes Mellitus type I
Juvenile diabetes

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014