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

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

Sponsors

Lead sponsor: Biodel

Source 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®.

Overall Status Completed
Start Date March 2011
Completion Date August 2011
Primary Completion Date August 2011
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Speed of absorption 480 minutes
Enrollment 13
Condition
Intervention

Intervention type: Drug

Intervention name: Insulin LISPRO

Description: Single doses of: 0.15 U/kg

Arm group label: Humalog®

Intervention type: Drug

Intervention name: recombinant human insulin

Description: Single doses of: 0.15 U/kg

Eligibility

Criteria:

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.

Gender: All

Minimum age: 19 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Linda Morrow, MD Principal Investigator Profil Institute for Clinical Research, Inc. (PICR)
Location
facility Profil Institute for Clinical Research, Inc. (PICR)
Location Countries

United States

Verification Date

July 2013

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Humalog®

Arm group type: Active Comparator

Description: Humalog®, administered subcutaneously on 1 occasion

Arm group label: BIOD- 105

Arm group type: Experimental

Description: BIOD- 105 administered subcutaneously on 1 occasion

Arm group label: BIOD-107

Arm group type: Experimental

Description: BIOD-107 administered subcutaneously on 1 occasion

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov