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

Biodel

Status and phase

Completed

Phase 2

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: BIOD-123

Drug: Lispro (Humalog)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01686620

3-201

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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