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
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
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus
Started Feb 2012
Shorter than P25 for phase_1 diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedJuly 26, 2013
July 1, 2013
29 days
July 24, 2013
July 24, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
0-30, 0-60, 0-90, 0-480, and 120-480 minutes
Study Arms (3)
BIOD-123
EXPERIMENTALSC administration of 0.20 U/kg
BIOD-125
EXPERIMENTALSC administration of 0.20 U/kg
Humalog
ACTIVE COMPARATORSC administration of 0.20 U/kg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biodellead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2013
First Posted
July 26, 2013
Study Start
February 1, 2012
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 26, 2013
Record last verified: 2013-07