Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
- Registration Number
- NCT01811849
- Lead Sponsor
- Biodel
- 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 BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Humalog Insulin LISPRO Subcutaneous injection BIOD-238 Insulin LISPRO Subcutaneous injection BIOD-250 Insulin LISPRO Subcutaneous injection
- Primary Outcome Measures
Name Time Method Time to 1/2 maximal insulin concentration 480 minutes
- Secondary Outcome Measures
Name Time Method Visual analog scale 30 minutes AUC 0-30 and AUC 0-60 60 minutes Time to 1/2 maximal insulin concentration after peak 480 minutes Time to maximal insulin concentration 480 minutes