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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: BIOD-123; Drug: Humalog; Drug: BIOD-125

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIOD-123; SC administration of 0.20 U/kg	Drug: BIOD-123
Experimental: BIOD-125; SC administration of 0.20 U/kg	Drug: BIOD-125
Active Comparator: Humalog; SC administration of 0.20 U/kg	Drug: Humalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.	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.	0-30, 0-60, 0-90, 0-480, and 120-480 minutes

Collaborators and Investigators

• Sponsor: Biodel

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): July 26, 2013
• Last Update Submitted That Met QC Criteria: July 24, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 3-101