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
NCT ID: NCT01908894
Last Updated: 2013-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2012-02-29
2012-03-31
Brief Summary
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Detailed Description
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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®
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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BIOD-123
SC administration of 0.20 U/kg
BIOD-123
BIOD-125
SC administration of 0.20 U/kg
BIOD-125
Humalog
SC administration of 0.20 U/kg
Humalog
Interventions
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BIOD-123
BIOD-125
Humalog
Eligibility Criteria
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Inclusion Criteria
2. BMI: ≥18 - ≤30 kg/m2
3. Diagnosed with type 1 diabetes mellitus for at least 1 year
4. Insulin antibody ≤10 μU/mL at screening
Exclusion Criteria
2. History of \>2 severe hypoglycemic events within the 3 months prior to screening
3. Serum C-peptide \>1.0 ng/mL
4. Hemoglobin A1c (HbA1c) \>10.0%
5. Females who were breast feeding, pregnant, or intending to become pregnant during the study
6. A sexually active person who was not using adequate contraceptive methods
7. Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
8. Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator
18 Years
70 Years
ALL
No
Sponsors
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Biodel
INDUSTRY
Responsible Party
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Other Identifiers
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3-101
Identifier Type: -
Identifier Source: org_study_id
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