Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
insulin aspart
insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Subjects with type 1 diabetes treated with insulin for at least 12 months
- BMI (Body Mass Index) between 18.0-29.0 kg/m^2
- Negative fasting C-peptide (below or equal to 0.6 ng/mL)
- HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
- Current treatment with insulin below or equal to 1.2 U/kg/day
- Subject should be in good health based on medical history, physical examination and routine laboratory data
Exclusion Criteria:
- Any known/suspected allergies to trial medication or similar products/devices
- A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- Clinically significant active disease of any kind
- Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
- Blood donation (more than 500 mL) within the previous 9 weeks
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Insulin aspart 100U/mL
Insulin aspart 200U/mL
Arm Description
Outcomes
Primary Outcome Measures
Area under the insulin aspart bolus concentration-time curve
Maximum plasma concentration (Cmax) of insulin aspart
Secondary Outcome Measures
Time to maximum concentration (Tmax) of insulin aspart
AUC (area under the curve) of insulin aspart
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01464099
Brief Title
Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
Official Title
A Single Center, Randomized, Double-blind, Balanced Two-period Cross-over Trial to Test for Bioequivalence Between a Marketed NovoLog® Formulation Containing 100 U/mL Versus a New NovoLog® Formulation Containing 200 U/mL in a Combined Regimen of a Continuous Subcutaneous Infusion and a Meal-time Bolus in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin aspart 100U/mL
Arm Type
Active Comparator
Arm Title
Insulin aspart 200U/mL
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
Primary Outcome Measure Information:
Title
Area under the insulin aspart bolus concentration-time curve
Time Frame
From 0 and up to 12 hours post bolus dose administration
Title
Maximum plasma concentration (Cmax) of insulin aspart
Time Frame
From 0 and up to 12 hours post bolus dose administration
Secondary Outcome Measure Information:
Title
Time to maximum concentration (Tmax) of insulin aspart
Time Frame
From 0-12 hours post bolus dose administration
Title
AUC (area under the curve) of insulin aspart
Time Frame
From -4 to 0 hours after dose administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with type 1 diabetes treated with insulin for at least 12 months
BMI (Body Mass Index) between 18.0-29.0 kg/m^2
Negative fasting C-peptide (below or equal to 0.6 ng/mL)
HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
Current treatment with insulin below or equal to 1.2 U/kg/day
Subject should be in good health based on medical history, physical examination and routine laboratory data
Exclusion Criteria:
Any known/suspected allergies to trial medication or similar products/devices
A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
Clinically significant active disease of any kind
Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
Blood donation (more than 500 mL) within the previous 9 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
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