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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT01686620
First received: September 13, 2012
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: BIOD-123
Drug: Lispro (Humalog)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • Change in HbA1C [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hypoglycemic event rates [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: Yes ]
  • Insulin dose [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: No ]
  • Daily blood glucose measures [ Time Frame: Baseline and 18 week treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: August 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686620

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

No publications provided

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT01686620     History of Changes
Other Study ID Numbers: 3-201
Study First Received: September 13, 2012
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biodel:
Mealtime insulin
Ultra-rapid acting insulin
Prandial insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014