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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

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

Details

• Lead Sponsor: Biodel
• Treatments: Insulin Lispro

Criteria

Inclusion Criteria:

1. Age: ≥18 - ≤70 years

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:

1. Type 2 diabetes mellitus

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