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

• Sponsor: Biodel (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01908894
• Collaborator: (none)
• Enrollment: 12
• Arms: 3
• Duration (Days): 29

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: BIOD-123; Drug: BIOD-125; Drug: Humalog	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Biodel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biodel
• ClinicalTrials.gov Identifier: NCT01908894
• Other Study ID Numbers: 3-101
• First Posted: Jul 26, 2013
• Last Update Posted: Jul 26, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Diabetes Mellitus; Insulin Lispro

Study Results

No Results Posted as of Jul 26, 2013