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Completed

NCT Number: NCT01334151

Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes

The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.

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Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institute for Clinical Research, Inc. (PICR)

Chula Vista, California, 91911, United States

About this study

The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects must present with the following:

  • Body Mass Index: ≥ 18 - ≤ 28 kg/m2
  • Diagnosed with type 1 diabetes mellitus for at least 1 year
  • Insulin antibody less than or equal to 10 μU/mL at screening

Exclusion criteria

Subjects presenting with any of the following will not be included in the study:

  • 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 screening visit
  • Regular smoking as assessed clinically by the Investigator.

Treatment and study plan

Insulin Lispro

Drug

Single doses of: 0.15 U/kg

recombinant human insulin

Drug

Single doses of: 0.15 U/kg

Primary outcomes

  1. Speed of absorption

    Time frame: 480 minutes

    The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).

Sponsors and collaborators

Lead sponsor

Biodel

Industry

Registry information

Official study title

A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2011
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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