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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biodel
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

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.