A Study Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

March 9, 2016 updated by: Biodel

A Randomized, Open-label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the safety and efficacy of BIOD-531 compared to Humalog®Mix 75/25 in patients with type 2 diabetes.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

BIOD-531 is a formulation of recombinant human insulin with a biphasic absorption profile characterized by rapid absorption (to prevent meal-time rises in blood glucose) and a secondary longer (basal) phase. The purpose of this trial is to evaluate glucose control and safety of BIOD-531 compared to a pre-mixed insulin which is commonly used to provide both meal-time and long acting insulin.

Study Type

Interventional

Enrollment (Actual)

13

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
    • Florida
      • Bradenton, Florida, United States, 34208
        • Meridien Research
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar Crosse Research Center
      • Springfield, Illinois, United States, 62711
        • Springfield Diabetes and Endocrine Center
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Diabetes and Endocrinology Consultants
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
    • Washington
      • Renton, Washington, United States, 98057
        • Ranier Clinical Research Center

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Established clinical diagnosis of type 2 diabetes, consistent with ADA classification criteria for 6 months or longer.
  • Body Mass Index 27 - 45 kg/square meter, inclusive.
  • Screening HbA1c between 7.5 and 11.0%, inclusive.
  • Up to two injections per day of U-100 basal (NPH, glargine, or detemir), pre-mixed, or self-mixed basal/prandial insulins or insulin analogs at stable total daily doses between 40 -200 units/day, inclusive, for ≥ 3 months prior to screening.

Exclusion Criteria:

  • Regular use of Humulin®R U-500 or sulfonylurea, exenatide (short-acting), repaglinide, or nateglinide within 1 month prior to screening.
  • History of bariatric surgery.
  • Subject has had one or more severe hypoglycemic episodes associated with seizure, coma, or unconsciousness within the past 6 months.
  • History of known hypersensitivity to any of the components in the study medication.
  • New York Heart Association (NYHA) Class III or IV functional capacity, unstable angina pectoris, myocardial infarction, severe peripheral vascular disease, ischemic strokes or transient ischemic attacks within 6 months of screening.
  • Systolic blood pressure ≥ 180 mmHg or sitting diastolic blood pressure ≥ 100 mmHg confirmed on repeat during screening visit.

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-531
BIOD-531 injected twice daily
Drug: BIOD-531
Active Comparator: Humalog® Mix 75/25
Humalog® Mix 75/25 injected twice daily
Drug: Humalog® Mix 75/25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Postprandial glucose excursions
Time Frame: 18 weeks
18 weeks
Change in weight
Time Frame: 18 weeks
18 weeks
Hypoglycemic event rates
Time Frame: 18 weeks
18 weeks

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

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-250

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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