Back to resultsPharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes Mellitus Type 1
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin LISPRO
recombinant human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 1
Eligibility Criteria
Inclusion Criteria:
Subjects must present with the following:
- 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
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
- 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 screening visit
- Regular smoking as assessed clinically by the Investigator.
Sites / Locations
- Profil Institute for Clinical Research, Inc. (PICR)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Humalog®
BIOD- 105
BIOD-107
Arm Description
Humalog®, administered subcutaneously on 1 occasion
BIOD- 105 administered subcutaneously on 1 occasion
BIOD-107 administered subcutaneously on 1 occasion
Outcomes
Primary Outcome Measures
Speed of absorption
The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01334151
Brief Title
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
Official Title
A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 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
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
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 primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.
Detailed Description
The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Humalog®
Arm Type
Active Comparator
Arm Description
Humalog®, administered subcutaneously on 1 occasion
Arm Title
BIOD- 105
Arm Type
Experimental
Arm Description
BIOD- 105 administered subcutaneously on 1 occasion
Arm Title
BIOD-107
Arm Type
Experimental
Arm Description
BIOD-107 administered subcutaneously on 1 occasion
Intervention Type
Drug
Intervention Name(s)
Insulin LISPRO
Intervention Description
Single doses of: 0.15 U/kg
Intervention Type
Drug
Intervention Name(s)
recombinant human insulin
Intervention Description
Single doses of: 0.15 U/kg
Primary Outcome Measure Information:
Title
Speed of absorption
Description
The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).
Time Frame
480 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must present with the following:
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
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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 screening visit
Regular smoking as assessed clinically by the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Morrow, MD
Organizational Affiliation
Profil Institute for Clinical Research, Inc. (PICR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil Institute for Clinical Research, Inc. (PICR)
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
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