Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT01334151
First received: April 11, 2011
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.


Condition Intervention Phase
Diabetes Mellitus Type 1
Drug: Insulin LISPRO
Drug: recombinant human insulin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • Speed of absorption [ Time Frame: 480 minutes ] [ Designated as safety issue: No ]
    The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).


Enrollment: 13
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Humalog®
Humalog®, administered subcutaneously on 1 occasion
Drug: Insulin LISPRO
Single doses of: 0.15 U/kg
Experimental: BIOD- 105
BIOD- 105 administered subcutaneously on 1 occasion
Drug: recombinant human insulin
Single doses of: 0.15 U/kg
Experimental: BIOD-107
BIOD-107 administered subcutaneously on 1 occasion
Drug: recombinant human insulin
Single doses of: 0.15 U/kg

Detailed Description:

The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must present with the following:

  1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2
  2. Diagnosed with type 1 diabetes mellitus for at least 1 year
  3. Insulin antibody less than or equal to 10 μU/mL at screening

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  1. Type 2 diabetes mellitus
  2. Serum C-peptide > 1.0 ng/mL
  3. HbA1c > 10.0%
  4. History of hypersensitivity to any of the components in the study medication
  5. Treatment with any other investigational drug in the last 30 days before screening visit
  6. Regular smoking as assessed clinically by the Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334151

Locations
United States, California
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Biodel
Investigators
Principal Investigator: Linda Morrow, MD Profil Institute for Clinical Research, Inc. (PICR)
  More Information

No publications provided

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT01334151     History of Changes
Other Study ID Numbers: VIAject 039J
Study First Received: April 11, 2011
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014