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OpenTrials
Completed

NCT Number: NCT01908894

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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®

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

BIOD-123

Drug

BIOD-125

Drug

Humalog

Drug

Primary outcomes

  1. Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biodel

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2013
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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