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Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01811849
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Biodel

Brief Summary:
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Insulin LISPRO Phase 1

Detailed Description:
The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

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Study Type : Interventional  (Clinical Trial)
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 Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
Study Start Date : August 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: BIOD-238
Subcutaneous injection
Drug: Insulin LISPRO
Experimental: BIOD-250
Subcutaneous injection
Drug: Insulin LISPRO
Active Comparator: Humalog
Subcutaneous injection
Drug: Insulin LISPRO



Primary Outcome Measures :
  1. Time to 1/2 maximal insulin concentration [ Time Frame: 480 minutes ]

Secondary Outcome Measures :
  1. Time to maximal insulin concentration [ Time Frame: 480 minutes ]
  2. Time to 1/2 maximal insulin concentration after peak [ Time Frame: 480 minutes ]
  3. Visual analog scale [ Time Frame: 30 minutes ]
  4. AUC 0-30 and AUC 0-60 [ Time Frame: 60 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥18 to ≤70 years
  • Body Mass Index: ≥18 and ≤35 kg/m2
  • Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • Serum C-peptide >1.0 ng/mL
  • HbA1c >10.0%
  • History of hypersensitivity to any of the components in the study medication
  • Treatment with any other investigational drug in the last 30 days before dosing.
  • Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

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Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT01811849    
Other Study ID Numbers: 4-102
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by Biodel:
diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs