A Phase 1 interventional study of Insulin LISPRO and recombinant human insulin in Diabetes Mellitus Type 1, sponsored by Biodel. Completed at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-07-26.
Sponsored by Biodel · Phase 1, Interventional, and Treatment
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®.
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®.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 13 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Biodel is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Subjects must present with the following:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Humalog®, administered subcutaneously on 1 occasion
Drug: Insulin LISPRO
BIOD- 105 administered subcutaneously on 1 occasion
Drug: recombinant human insulin
BIOD-107 administered subcutaneously on 1 occasion
Drug: recombinant human insulin
Single doses of: 0.15 U/kg
Single doses of: 0.15 U/kg
Speed of absorption
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).
Time frame: 480 minutes
The record gives a start of Mar 2011, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Biodel