Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 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: NCT01811849
• Other study ID #: 4-102
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2013
• Last updated: March 14, 2013
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

Description:

The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Age: =18 to =70 years

• Body Mass Index: =18 and =35 kg/m2

• Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

Exclusion Criteria:

• Type 2 diabetes mellitus

• Serum C-peptide >1.0 ng/mL

• HbA1c >10.0%

• History of hypersensitivity to any of the components in the study medication

• Treatment with any other investigational drug in the last 30 days before dosing.

• Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Insulin LISPRO

• Insulin LISPRO

• Insulin LISPRO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to 1/2 maximal insulin concentration		480 minutes	No
Secondary	Time to maximal insulin concentration		480 minutes	No
Secondary	Time to 1/2 maximal insulin concentration after peak		480 minutes	No
Secondary	Visual analog scale		30 minutes	No
Secondary	AUC 0-30 and AUC 0-60		60 minutes	No