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

Phase 2

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: BIOD-123; Drug: Lispro (Humalog)

• Registration Number: NCT01686620
• Lead Sponsor: Biodel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-18
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-07
• Disposition First Submitted: 2015-07-22
• Disposition First Submitted QC: 2015-07-22
• Last Update Submitted: 2015-07-22
• Disposition First Posted: 2015-07-28
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIOD-123	BIOD-123	BIOD-123 used as prandial insulin
Lispro (Humalog)	Lispro (Humalog)	Lispro (Humalog) used as prandial insulin

Primary Outcome Measures

Name	Time	Method
Change in HbA1C	Baseline and 18 week treatment period

Secondary Outcome Measures

Name	Time	Method
Hypoglycemic event rates	Baseline and 18 week treatment period
Insulin dose	Baseline and 18 week treatment period
Daily blood glucose measures	Baseline and 18 week treatment period

Trial Locations

Locations (33)

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States

Profil Research Institute; 🇺🇸 Chula Vista, California, United States

John Muir Physician Network Clinical Research Center; 🇺🇸 Concord, California, United States

Scripps Whittier Diabetes Institute; 🇺🇸 La Jolla, California, United States

Private Practice - Richard Cherlin, MD.; 🇺🇸 Los Gatos, California, United States

Providence Clinical Research Pharmaseek; 🇺🇸 North Hollywood, California, United States

Monteagle Medical Center; 🇺🇸 San Francisco, California, United States

Mills-Peninsula Health Services; 🇺🇸 San Mateo, California, United States

The Center for Diabetes and Endocrine Care; 🇺🇸 Hollywood, Florida, United States

University of Miami Diabetes Research Institute; 🇺🇸 Miami, Florida, United States

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