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®.
Drug: Insulin LISPRO
Drug: recombinant human insulin
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Locations near you
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Full eligibility criteria for NCT01334151
Ages eligible for Study
19 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
Subjects must present with the following:
Body Mass Index: ≥ 18 - ≤ 28 kg/m2
Diagnosed with type 1 diabetes mellitus for at least 1 year
Insulin antibody less than or equal to 10 μU/mL at screening
Subjects presenting with any of the following will not be included in the study:
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 screening visit
Regular smoking as assessed clinically by the Investigator.
All locations for NCT01334151
United States (1)
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, United States, 91911
View full eligibility
Tris trial is registered with FDA with number: NCT01334151. The sponsor of the trial is Biodel and it is looking for 13 volunteers for the current phase.
Official trial 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
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