Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01811849

Enrollment

Registered

2013-03-15

Start date

2012-08-31

Completion date

2012-12-31

Last updated

2013-03-15

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

Conditions

Type 1 Diabetes

Keywords

diabetes

Brief summary

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

Detailed description

The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

Interventions

DRUGInsulin LISPRO

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Age: ≥18 to ≤70 years * Body Mass Index: ≥18 and ≤35 kg/m2 * Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

Exclusion criteria

* Type 2 diabetes mellitus * Serum C-peptide \>1.0 ng/mL * HbA1c \>10.0% * History of hypersensitivity to any of the components in the study medication * Treatment with any other investigational drug in the last 30 days before dosing. * Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

Design outcomes

Primary

Measure	Time frame
Time to 1/2 maximal insulin concentration	480 minutes

Secondary

Measure	Time frame
Time to maximal insulin concentration	480 minutes
Time to 1/2 maximal insulin concentration after peak	480 minutes
Visual analog scale	30 minutes
AUC 0-30 and AUC 0-60	60 minutes

Outcome results

None listed

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