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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Biodel · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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®

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BIOD-123
DRUG	BIOD-125
DRUG	Humalog

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2013-07-26
• Last updated: 2013-07-26