Status:
COMPLETED
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
Lead Sponsor:
Biodel
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
Detailed Description
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog. The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-1...
Eligibility Criteria
Inclusion
- Age: ≥18 - ≤70 years
- BMI: ≥18 - ≤30 kg/m2
- Diagnosed with type 1 diabetes mellitus for at least 1 year
- Insulin antibody ≤10 μU/mL at screening
Exclusion
- Type 2 diabetes mellitus
- History of \>2 severe hypoglycemic events within the 3 months prior to screening
- Serum C-peptide \>1.0 ng/mL
- Hemoglobin A1c (HbA1c) \>10.0%
- Females who were breast feeding, pregnant, or intending to become pregnant during the study
- A sexually active person who was not using adequate contraceptive methods
- Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
- Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01908894
Start Date
February 1 2012
End Date
March 1 2012
Last Update
July 26 2013
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