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

Diabetes Mellitus Type 1 Clinical Trial

Official title:

A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 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: NCT01334151
• Other study ID #: VIAject 039J
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2011
• Last updated: July 24, 2013
• Start date: March 2011
• Est. completion date: August 2011

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 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®.

Description:

The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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.

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 Type 1
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insulin LISPRO
Single doses of: 0.15 U/kg
• recombinant human insulin
Single doses of: 0.15 U/kg

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research, Inc. (PICR)	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed of absorption	The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).	480 minutes	No