Clinical trial NCT01686620: A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Mealtime insulin
Ultra-rapid acting insulin
Prandial insulin
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in HbA1C
timeFrame: Baseline and 18 week treatment period
Secondary outcomes:
measure: Hypoglycemic event rates
timeFrame: Baseline and 18 week treatment period
measure: Insulin dose
timeFrame: Baseline and 18 week treatment period
measure: Daily blood glucose measures
timeFrame: Baseline and 18 week treatment period
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Chula Vista
country: United States
facility: Profil Research Institute
state: California
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: Los Gatos
country: United States
facility: Private Practice - Richard Cherlin, MD.
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research Pharmaseek
state: California
city: San Francisco
country: United States
facility: Monteagle Medical Center
state: California
city: San Mateo
country: United States
facility: Mills-Peninsula Health Services
state: California
city: Hollywood
country: United States
facility: The Center for Diabetes and Endocrine Care
state: Florida
city: Miami
country: United States
facility: University of Miami Diabetes Research Institute
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research Pharmaseek
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center PA
state: Idaho
city: Wichita
country: United States
facility: MidAmerica Diabetes Associates, PA
state: Kansas
city: Lexington
country: United States
facility: Kentucky Diabetes
state: Kentucky
city: Rockville
country: United States
facility: Diabetes & Glandular Disease Research
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Henderson
country: United States
facility: Desert Endocrinolgy
state: Nevada
city: Syracuse
country: United States
facility: Research Foundation of SUNY Upstate Medical University
state: New York
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants, PC
state: North Carolina
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services, LLC
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Dallas
country: United States
facility: Mountain Diabetes & Endrocrine Center
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Research Center
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor Endocrine Center
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Sonterra Clinical Research
state: Texas
city: Olympia
country: United States
facility: Capital Clinical Research Center
state: Washington
city: Renton
country: United States
facility: Ranier Clinical Research, Inc
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
Study officials:
References: