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

Biodel13 enrolled

Overview

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®.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus Type 1

Interventions

Insulin LISPRODRUG

Single doses of: 0.15 U/kg

recombinant human insulinDRUG

Single doses of: 0.15 U/kg

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Profil Institute for Clinical Research, Inc. (PICR)

Chula Vista, California, United States

Outcomes

Primary Outcomes

Speed of absorption

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).

Time frame: 480 minutes

Data from ClinicalTrials.gov

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