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

Biodel

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 1

Treatments: Drug: Insulin LISPRO; Drug: recombinant human insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01334151

VIAject 039J

Details and patient eligibility

About

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®.

Full 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®.

Enrollment: 13 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 3 patient groups

Humalog®

Active Comparator group

Description:

Humalog®, administered subcutaneously on 1 occasion

Treatment:

Drug: Insulin LISPRO

BIOD- 105

Experimental group

Description:

BIOD- 105 administered subcutaneously on 1 occasion

Treatment:

Drug: recombinant human insulin

BIOD-107

Experimental group

Description:

BIOD-107 administered subcutaneously on 1 occasion

Treatment:

Drug: recombinant human insulin