Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration

Biodel

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: BIOD-123; Drug: BIOD-125; Drug: Humalog

Study type: Interventional

Funder types: Industry

Identifiers

NCT01908894

3-101

Details and patient eligibility

About

The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

Full description

The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: ≥18 - ≤70 years
2. BMI: ≥18 - ≤30 kg/m2
3. Diagnosed with type 1 diabetes mellitus for at least 1 year
4. Insulin antibody ≤10 μU/mL at screening

Exclusion criteria

1. Type 2 diabetes mellitus
2. History of >2 severe hypoglycemic events within the 3 months prior to screening
3. Serum C-peptide >1.0 ng/mL
4. Hemoglobin A1c (HbA1c) >10.0%
5. Females who were breast feeding, pregnant, or intending to become pregnant during the study
6. A sexually active person who was not using adequate contraceptive methods
7. Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
8. Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator

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-123

Experimental group

Description:

SC administration of 0.20 U/kg

Treatment:

Drug: BIOD-123

BIOD-125

Experimental group

Description:

SC administration of 0.20 U/kg

Treatment:

Drug: BIOD-125

Humalog

Active Comparator group

Description:

SC administration of 0.20 U/kg

Treatment:

Drug: Humalog