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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-08-31

Brief Summary

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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®.

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Detailed Description

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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®.

Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Humalog®

Humalog®, administered subcutaneously on 1 occasion

Group Type ACTIVE_COMPARATOR

Insulin LISPRO

Intervention Type DRUG

Single doses of: 0.15 U/kg

BIOD- 105

BIOD- 105 administered subcutaneously on 1 occasion

Group Type EXPERIMENTAL

recombinant human insulin

Intervention Type DRUG

Single doses of: 0.15 U/kg

BIOD-107

BIOD-107 administered subcutaneously on 1 occasion

Group Type EXPERIMENTAL

recombinant human insulin

Intervention Type DRUG

Single doses of: 0.15 U/kg

Interventions

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Insulin LISPRO

Single doses of: 0.15 U/kg

Intervention Type DRUG

recombinant human insulin

Single doses of: 0.15 U/kg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No