Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Insulin LISPRO
Insulin LISPRO
Insulin LISPRO
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring diabetes
Eligibility Criteria
Inclusion Criteria:
- Age: ≥18 to ≤70 years
- Body Mass Index: ≥18 and ≤35 kg/m2
- Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
Exclusion Criteria:
- Type 2 diabetes mellitus
- Serum C-peptide >1.0 ng/mL
- HbA1c >10.0%
- History of hypersensitivity to any of the components in the study medication
- Treatment with any other investigational drug in the last 30 days before dosing.
- Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
BIOD-238
BIOD-250
Humalog
Arm Description
Subcutaneous injection
Subcutaneous injection
Subcutaneous injection
Outcomes
Primary Outcome Measures
Time to 1/2 maximal insulin concentration
Secondary Outcome Measures
Time to maximal insulin concentration
Time to 1/2 maximal insulin concentration after peak
Visual analog scale
AUC 0-30 and AUC 0-60
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01811849
Brief Title
Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
Official Title
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biodel
4. Oversight
5. Study Description
Brief Summary
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes
Detailed Description
The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIOD-238
Arm Type
Experimental
Arm Description
Subcutaneous injection
Arm Title
BIOD-250
Arm Type
Experimental
Arm Description
Subcutaneous injection
Arm Title
Humalog
Arm Type
Active Comparator
Arm Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Insulin LISPRO
Intervention Type
Drug
Intervention Name(s)
Insulin LISPRO
Intervention Type
Drug
Intervention Name(s)
Insulin LISPRO
Primary Outcome Measure Information:
Title
Time to 1/2 maximal insulin concentration
Time Frame
480 minutes
Secondary Outcome Measure Information:
Title
Time to maximal insulin concentration
Time Frame
480 minutes
Title
Time to 1/2 maximal insulin concentration after peak
Time Frame
480 minutes
Title
Visual analog scale
Time Frame
30 minutes
Title
AUC 0-30 and AUC 0-60
Time Frame
60 minutes
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:
Age: ≥18 to ≤70 years
Body Mass Index: ≥18 and ≤35 kg/m2
Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
Exclusion Criteria:
Type 2 diabetes mellitus
Serum C-peptide >1.0 ng/mL
HbA1c >10.0%
History of hypersensitivity to any of the components in the study medication
Treatment with any other investigational drug in the last 30 days before dosing.
Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
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