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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 1
• Interventions: Drug: Insulin LISPRO; Drug: recombinant human insulin

• Registration Number: NCT01334151
• Lead Sponsor: Biodel

Brief 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®.

Detailed Description

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®.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Subjects must present with the following:

1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2
2. Diagnosed with type 1 diabetes mellitus for at least 1 year
3. 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:

1. Type 2 diabetes mellitus
2. Serum C-peptide > 1.0 ng/mL
3. HbA1c > 10.0%
4. History of hypersensitivity to any of the components in the study medication
5. Treatment with any other investigational drug in the last 30 days before screening visit
6. Regular smoking as assessed clinically by the Investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Humalog®	Insulin LISPRO	Humalog®, administered subcutaneously on 1 occasion
BIOD- 105	recombinant human insulin	BIOD- 105 administered subcutaneously on 1 occasion
BIOD-107	recombinant human insulin	BIOD-107 administered subcutaneously on 1 occasion

Primary Outcome Measures

Name	Time	Method
Speed of absorption	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).

Trial Locations

Locations (1)

Profil Institute for Clinical Research, Inc. (PICR); 🇺🇸 Chula Vista, California, United States