Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
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
1 other identifier
interventional
13
1 country
1
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2011
Shorter than P25 for phase_1
1 active site
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
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJuly 26, 2013
July 1, 2013
5 months
April 11, 2011
July 24, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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).
480 minutes
Study Arms (3)
Humalog®
ACTIVE COMPARATORHumalog®, administered subcutaneously on 1 occasion
BIOD- 105
EXPERIMENTALBIOD- 105 administered subcutaneously on 1 occasion
BIOD-107
EXPERIMENTALBIOD-107 administered subcutaneously on 1 occasion
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biodellead
Study Sites (1)
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, 91911, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Morrow, MD
Profil Institute for Clinical Research, Inc. (PICR)
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
April 11, 2011
First Posted
April 13, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
July 26, 2013
Record last verified: 2013-07