Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biodel
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

Subjects must present with the following:

1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2

2. Diagnosed with type 1 diabetes mellitus for at least 1 year

3. Insulin antibody less than or equal to 10 μU/mL at screening

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. Type 2 diabetes mellitus

2. Serum C-peptide > 1.0 ng/mL

3. HbA1c > 10.0%

4. History of hypersensitivity to any of the components in the study medication

5. Treatment with any other investigational drug in the last 30 days before screening visit

6. Regular smoking as assessed clinically by the Investigator.