Skip to main content
OpenTrials
Completed

NCT Number: NCT01811849

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes 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

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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®.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Insulin Lispro

Drug

Primary outcomes

  1. Time to 1/2 maximal insulin concentration

    Time frame: 480 minutes

Secondary outcomes

  1. Time to maximal insulin concentration

    Time frame: 480 minutes

  2. Time to 1/2 maximal insulin concentration after peak

    Time frame: 480 minutes

  3. Visual analog scale

    Time frame: 30 minutes

  4. AUC 0-30 and AUC 0-60

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

Biodel

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2013
Registry last updated
Mar 15, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.