BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance

January 15, 2016 updated by: Biodel

A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin® R U-500 and Humalog® Mix75/25™ in Subjects With Type 2 DM Who Are Treated With ≥ 150 Units of Insulin Per Day

The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.

Study Overview

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • 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

    • 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 25 kg/m2
  • Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening
  • HbA1c < 10.0%

Exclusion Criteria:

  • History of bariatric surgery
  • Corticosteroid therapy
  • Significant cardiovascular or other major organ disease
  • Females who are breast feeding or pregnant
  • A sexually active person not using adequate contraceptive methods

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIOD-531 pre-meal
Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
Active Comparator: Humalog Mix 75/25 pre-meal
Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
Active Comparator: Humulin R U-500 pre-meal
Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
Experimental: BIOD-531 post-meal
Subcutaneous injections of 1.2 U/kg 20 minutes after the start of a standardized breakfast and 0.8 U/kg 20 minutes after the start of a standardized dinner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-breakfast glucose exposure (AUC)
Time Frame: 0-330 minutes
0-330 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
Time Frame: 0-330 and 660-1020 minutes
0-330 and 660-1020 minutes
Insulin exposure (AUC)
Time Frame: 0-1440 minutes
0-1440 minutes
Maximal insulin concentration
Time Frame: 0-330 and 660-1020 minutes
0-330 and 660-1020 minutes
Post-lunch and post-dinner glucose exposures (AUC)
Time Frame: 330-660 and 660-1020 minutes
330-660 and 660-1020 minutes
Injection site toleration (VAS and severity scales)
Time Frame: 30 and 690 minutes
30 and 690 minutes

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Laurie Han-Conrad, MD, Profil Institute for Clinical Research, Inc.

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

May 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 3-151

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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