Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
NCT ID: NCT01811849
Last Updated: 2013-03-15
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
2012-08-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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BIOD-238
Subcutaneous injection
Insulin LISPRO
BIOD-250
Subcutaneous injection
Insulin LISPRO
Humalog
Subcutaneous injection
Insulin LISPRO
Interventions
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Insulin LISPRO
Insulin LISPRO
Insulin LISPRO
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index: ≥18 and ≤35 kg/m2
* Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
Exclusion Criteria
* 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 dosing.
* Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.
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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4-102
Identifier Type: -
Identifier Source: org_study_id
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