Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

Biodel

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Drug: Insulin LISPRO

Study type: Interventional

Funder types: Industry

Identifiers

NCT01811849

4-102

Details and patient eligibility

About

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

Full description

The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: ≥18 to ≤70 years
• Body Mass Index: ≥18 and ≤35 kg/m2
• Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

Exclusion criteria

• Type 2 diabetes mellitus
• Serum C-peptide >1.0 ng/mL
• HbA1c >10.0%
• History of hypersensitivity to any of the components in the study medication
• Treatment with any other investigational drug in the last 30 days before dosing.
• Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups

BIOD-238

Experimental group

Description:

Subcutaneous injection

Treatment:

Drug: Insulin LISPRO

Drug: Insulin LISPRO

Drug: Insulin LISPRO

BIOD-250

Experimental group

Description:

Subcutaneous injection

Treatment:

Drug: Insulin LISPRO

Drug: Insulin LISPRO

Drug: Insulin LISPRO

Humalog

Active Comparator group

Description:

Subcutaneous injection

Treatment:

Drug: Insulin LISPRO

Drug: Insulin LISPRO

Drug: Insulin LISPRO