Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration

A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 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

NCT01908894

Enrollment

Registered

2013-07-26

Start date

2012-02-29

Completion date

2012-03-31

Last updated

2013-07-26

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

Conditions

Diabetes Mellitus

Brief summary

The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

Detailed description

The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog. The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®

Interventions

DRUGBIOD-123

DRUGBIOD-125

DRUGHumalog

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

1. Age: ≥18 - ≤70 years 2. BMI: ≥18 - ≤30 kg/m2 3. Diagnosed with type 1 diabetes mellitus for at least 1 year 4. Insulin antibody ≤10 μU/mL at screening

Exclusion criteria

1. Type 2 diabetes mellitus 2. History of \>2 severe hypoglycemic events within the 3 months prior to screening 3. Serum C-peptide \>1.0 ng/mL 4. Hemoglobin A1c (HbA1c) \>10.0% 5. Females who were breast feeding, pregnant, or intending to become pregnant during the study 6. A sexually active person who was not using adequate contraceptive methods 7. Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C 8. Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator

Design outcomes

Primary

Measure	Time frame	Description
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.	0-30, 0-60, 0-90, 0-480, and 120-480 minutes	Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.

Outcome results

None listed

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