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

NCT01334151 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-07-26

No results posted yet for this study

Summary

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®.

Conditions

  • Diabetes Mellitus Type 1

Interventions

DRUG

Insulin LISPRO

Single doses of: 0.15 U/kg

DRUG

recombinant human insulin

Single doses of: 0.15 U/kg

Sponsors & Collaborators

  • Biodel

    lead INDUSTRY

Principal Investigators

  • Linda Morrow, MD · Profil Institute for Clinical Research, Inc. (PICR)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01334151 on ClinicalTrials.gov