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

March 14, 2013 updated by: Biodel

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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®.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIOD-238
Subcutaneous injection
Drug: Insulin LISPRO
Experimental: BIOD-250
Subcutaneous injection
Drug: Insulin LISPRO
Active Comparator: Humalog
Subcutaneous injection
Drug: Insulin LISPRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to 1/2 maximal insulin concentration
Time Frame: 480 minutes
480 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to maximal insulin concentration
Time Frame: 480 minutes
480 minutes
Time to 1/2 maximal insulin concentration after peak
Time Frame: 480 minutes
480 minutes
Visual analog scale
Time Frame: 30 minutes
30 minutes
AUC 0-30 and AUC 0-60
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biodel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 15, 2013

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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