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

Diabetes Mellitus Clinical Trial

Official title:

A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908894
• Other study ID #: 3-101
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2013
• Last updated: July 24, 2013
• Start date: February 2012
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• BIOD-123

• BIOD-125

• Humalog

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.	Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.	0-30, 0-60, 0-90, 0-480, and 120-480 minutes	No