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

July 24, 2013 updated by: Biodel

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

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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®.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Profil Institute For Clinical Research, Inc. (Picr)

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

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
Active Comparator: Humalog®
Humalog®, administered subcutaneously on 1 occasion
Drug: Insulin LISPRO
Single doses of: 0.15 U/kg
Experimental: BIOD- 105
BIOD- 105 administered subcutaneously on 1 occasion
Drug: recombinant human insulin
Single doses of: 0.15 U/kg
Experimental: BIOD-107
BIOD-107 administered subcutaneously on 1 occasion
Drug: recombinant human insulin
Single doses of: 0.15 U/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of absorption
Time Frame: 480 minutes
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

Collaborators and Investigators

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

Sponsor

Biodel

Investigators

  • Principal Investigator: Linda Morrow, MD, Profil Institute For Clinical Research, Inc. (Picr)

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

March 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIAject 039J

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.

Clinical Trials on Diabetes Mellitus Type 1

Clinical Trials on Insulin LISPRO

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe