Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dance Biopharm Inc.
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 U/kg/day.

• Body mass index 25-40 kg/m2

• Hemoglobin A1c 6.5-9.5%

• Forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values.

• Fasting c-peptide less than 1 nmol/L

Exclusion Criteria:

• Any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke.

• Active or chronic pulmonary disease.

• Any major disorder other than type 2 diabetes.

• Decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months.

• Proliferative retinopathy or maculopathy or severe neuropathy.