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
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
VIAject™
Regular Human Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Insulin, Diabetes Mellitus type I, Juvenile diabetes
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
VIAject™
Regular Human Insulin
Outcomes
Primary Outcome Measures
Change in HbA1c
To evaluate the mean changes in hemoglobin A1c (HbA1c) from baseline to the end of the study in subjects with type 1 diabetes after treatment for 6 months with Viaject in comparison to the mean changes in HbA1c from baseline to end of study in subjects treated with regular human insulin (RHI).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00542724
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biodel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Insulin, Diabetes Mellitus type I, Juvenile diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
462 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
VIAject™
Arm Title
B
Arm Type
Active Comparator
Arm Description
Regular Human Insulin
Intervention Type
Drug
Intervention Name(s)
VIAject™
Intervention Description
Dosage as individually required
Intervention Type
Drug
Intervention Name(s)
Regular Human Insulin
Intervention Description
Dosage as individually required
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
To evaluate the mean changes in hemoglobin A1c (HbA1c) from baseline to the end of the study in subjects with type 1 diabetes after treatment for 6 months with Viaject in comparison to the mean changes in HbA1c from baseline to end of study in subjects treated with regular human insulin (RHI).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Klonoff, M.D., F.A.C.P.
Organizational Affiliation
Diabetes Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
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
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