A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)

July 22, 2015 updated by: Biodel

A Randomized, Parallel Group Trial Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes Using Basal-bolus Insulin Injection Therapy

The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2

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
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
      • Chula Vista, California, United States, 91911
        • Profil Research Institute
      • Concord, California, United States, 94520
        • John Muir Physician Network Clinical Research Center
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Institute
      • Los Gatos, California, United States, 95032
        • Private Practice - Richard Cherlin, MD.
      • North Hollywood, California, United States, 91606
        • Providence Clinical Research Pharmaseek
      • San Francisco, California, United States, 94110
        • Monteagle Medical Center
      • San Mateo, California, United States, 94401
        • Mills-Peninsula Health Services
    • Florida
      • Hollywood, Florida, United States, 33021
        • The Center for Diabetes and Endocrine Care
      • Miami, Florida, United States, 33136
        • University of Miami Diabetes Research Institute
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research Pharmaseek
    • Georgia
      • Atlanta, Georgia, United States, 30309-1764
        • Atlanta Diabetes Associates
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center PA
    • Kansas
      • Wichita, Kansas, United States, 67226
        • MidAmerica Diabetes Associates, PA
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Kentucky Diabetes
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Diabetes & Glandular Disease Research
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Henry Ford Health System
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Desert Endocrinolgy
    • New York
      • Syracuse, New York, United States, 13210
        • Research Foundation of SUNY Upstate Medical University
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Sentral Clinical Research Services, LLC
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Diabetes and Endocrinology
      • Dallas, Texas, United States, 75231
        • Research Institute Of Dallas
      • Dallas, Texas, United States, 75246
        • Baylor Endocrine Center
      • Dallas, Texas, United States, 28803
        • Mountain Diabetes & Endrocrine Center
      • Dallas, Texas, United States, 75006
        • Dallas Diabetes and Endocrine Research Center
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes and Endocrinology
      • San Antonio, Texas, United States, 78258
        • Sonterra Clinical Research
    • Washington
      • Olympia, Washington, United States, 98502
        • Capital Clinical Research Center
      • Renton, Washington, United States, 98507
        • Ranier Clinical Research, Inc
      • Spokane, Washington, United States, 99202
        • Rockwood Clinic

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.
  • Age: 18 years old, or older.
  • Body Mass Index: between 18 and 35 kg/m2, inclusive.
  • Willing to use insulin glargine as the only basal insulin throughout the duration of the trial.
  • Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial.

Exclusion Criteria:

  • History of known hypersensitivity to any of the components in the study medication
  • Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study.
  • Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed.
  • Consistent recent hypoglycemic unawareness within the last six months
  • History of more than two severe hypoglycemic events within six months prior to screening

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIOD-123
BIOD-123 used as prandial insulin
Drug: BIOD-123
Active Comparator: Lispro (Humalog)
Lispro (Humalog) used as prandial insulin
Drug: Lispro (Humalog)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1C
Time Frame: Baseline and 18 week treatment period
Baseline and 18 week treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycemic event rates
Time Frame: Baseline and 18 week treatment period
Baseline and 18 week treatment period
Insulin dose
Time Frame: Baseline and 18 week treatment period
Baseline and 18 week treatment period
Daily blood glucose measures
Time Frame: Baseline and 18 week treatment period
Baseline and 18 week treatment period

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)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-201

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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