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

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: BIOD-125; Drug: Humalog; Drug: BIOD-123

• Registration Number: NCT01908894
• Lead Sponsor: Biodel

Brief Summary

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

Detailed 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®

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-07
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Last Update Submitted: 2013-07-24
• Study First Posted: 2013-07-26
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIOD-125	BIOD-125	SC administration of 0.20 U/kg
Humalog	Humalog	SC administration of 0.20 U/kg
BIOD-123	BIOD-123	SC administration of 0.20 U/kg

Primary Outcome Measures

Name	Time	Method
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.	0-30, 0-60, 0-90, 0-480, and 120-480 minutes	Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.