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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01686620

Enrollment

132

Registered

2012-09-18

Start date

2012-08-31

Completion date

2013-06-30

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Mealtime insulin, Ultra-rapid acting insulin, Prandial insulin

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.

Interventions

DRUGBIOD-123

DRUGLispro (Humalog)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1C	Baseline and 18 week treatment period

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026