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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686620
• Other study ID #: 3-201
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2012
• Last updated: July 22, 2015
• Start date: August 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2015
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• BIOD-123

• Lispro (Humalog)

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	Mercury Street Medical	Butte	Montana
United States	Profil Research Institute	Chula Vista	California
United States	Sentral Clinical Research Services, LLC	Cincinnati	Ohio
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Baylor Endocrine Center	Dallas	Texas
United States	Dallas Diabetes and Endocrine Research Center	Dallas	Texas
United States	Mountain Diabetes & Endrocrine Center	Dallas	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Desert Endocrinolgy	Henderson	Nevada
United States	The Center for Diabetes and Endocrine Care	Hollywood	Florida
United States	Rocky Mountain Diabetes and Osteoporosis Center PA	Idaho Falls	Idaho
United States	Scripps Whittier Diabetes Institute	La Jolla	California
United States	Kentucky Diabetes	Lexington	Kentucky
United States	Private Practice - Richard Cherlin, MD.	Los Gatos	California
United States	University of Miami Diabetes Research Institute	Miami	Florida
United States	Diabetes & Endocrinology Consultants, PC	Morehead City	North Carolina
United States	Providence Clinical Research Pharmaseek	North Hollywood	California
United States	Capital Clinical Research Center	Olympia	Washington
United States	Progressive Medical Research Pharmaseek	Port Orange	Florida
United States	Oregon Health Sciences University	Portland	Oregon
United States	Ranier Clinical Research, Inc	Renton	Washington
United States	Diabetes & Glandular Disease Research	Rockville	Maryland
United States	Endocrine Research Solutions	Roswell	Georgia
United States	Texas Diabetes and Endocrinology	Round Rock	Texas
United States	Sonterra Clinical Research	San Antonio	Texas
United States	Monteagle Medical Center	San Francisco	California
United States	Mills-Peninsula Health Services	San Mateo	California
United States	Rockwood Clinic	Spokane	Washington
United States	Research Foundation of SUNY Upstate Medical University	Syracuse	New York
United States	MidAmerica Diabetes Associates, PA	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1C		Baseline and 18 week treatment period	Yes
Secondary	Hypoglycemic event rates		Baseline and 18 week treatment period	Yes
Secondary	Insulin dose		Baseline and 18 week treatment period	No
Secondary	Daily blood glucose measures		Baseline and 18 week treatment period	No