Back to resultsPharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIOD-123
BIOD-125
Humalog
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Age: ≥18 - ≤70 years
- BMI: ≥18 - ≤30 kg/m2
- Diagnosed with type 1 diabetes mellitus for at least 1 year
- Insulin antibody ≤10 μU/mL at screening
Exclusion Criteria:
- Type 2 diabetes mellitus
- History of >2 severe hypoglycemic events within the 3 months prior to screening
- Serum C-peptide >1.0 ng/mL
- Hemoglobin A1c (HbA1c) >10.0%
- Females who were breast feeding, pregnant, or intending to become pregnant during the study
- A sexually active person who was not using adequate contraceptive methods
- Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
- Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
BIOD-123
BIOD-125
Humalog
Arm Description
SC administration of 0.20 U/kg
SC administration of 0.20 U/kg
SC administration of 0.20 U/kg
Outcomes
Primary Outcome Measures
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.
Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01908894
Brief Title
Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration
Official Title
A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 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
February 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biodel
4. Oversight
5. Study Description
Brief Summary
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
Detailed Description
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
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-123
Arm Type
Experimental
Arm Description
SC administration of 0.20 U/kg
Arm Title
BIOD-125
Arm Type
Experimental
Arm Description
SC administration of 0.20 U/kg
Arm Title
Humalog
Arm Type
Active Comparator
Arm Description
SC administration of 0.20 U/kg
Intervention Type
Drug
Intervention Name(s)
BIOD-123
Intervention Type
Drug
Intervention Name(s)
BIOD-125
Intervention Type
Drug
Intervention Name(s)
Humalog
Primary Outcome Measure Information:
Title
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.
Description
Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.
Time Frame
0-30, 0-60, 0-90, 0-480, and 120-480 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 - ≤70 years
BMI: ≥18 - ≤30 kg/m2
Diagnosed with type 1 diabetes mellitus for at least 1 year
Insulin antibody ≤10 μU/mL at screening
Exclusion Criteria:
Type 2 diabetes mellitus
History of >2 severe hypoglycemic events within the 3 months prior to screening
Serum C-peptide >1.0 ng/mL
Hemoglobin A1c (HbA1c) >10.0%
Females who were breast feeding, pregnant, or intending to become pregnant during the study
A sexually active person who was not using adequate contraceptive methods
Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration
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