A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin R U-500 and Humalog Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day
Sponsor study identifier
interventional
12
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
Not reported
Date not reportedThe study is to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 2014
Actual (reported)August 7, 2014
Actual (reported)August 11, 2014
Actual (reported)Post-standardized meal glucose exposure (AUC)
0-120 minutes after meal
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
0-720 minutes
Insulin exposure (AUC)
Various time frames over 720 minutes
Maximal insulin concentration
0-720 minutes
Post breakfast and post-lunch glucose exposure (AUC)
Various times frames over 720 minutes
Post-breakfast and post-lunch maximal glucose concentrations
0-720 minutes
Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast
Profil Institute for Clinical Research
Chula Vista, California, United States
12 participants (actual enrollment reported by the registry).
First Submitted
August 7, 2014
First Posted
August 11, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast
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Primary Completion
July 2014
Actual (reported)Last Updated
February 8, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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