Status:
COMPLETED
Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
Lead Sponsor:
Biodel
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes
Detailed Description
The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and B...
Eligibility Criteria
Inclusion
- Age: ≥18 to ≤70 years
- Body Mass Index: ≥18 and ≤35 kg/m2
- Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
Exclusion
- 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 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.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01811849
Start Date
August 1 2012
End Date
December 1 2012
Last Update
March 15 2013
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