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

Completed · Phase 1

Conditions studied: Diabetes Mellitus Type 1

In brief

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®.

Key facts

Study ID

NCT01334151

Run by

Biodel

People needed

13

Starts

2011-03-01

Expected to finish

2011-08-01

Last updated by the study team

2013-07-26

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Profil Institute for Clinical Research, Inc. (PICR) — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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