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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in HbA1C
Time Frame: Baseline and 18 week treatment period
Baseline and 18 week treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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