Clinical Trials Directory

Trials / Terminated

TerminatedNCT00747006

Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake

A Phase 2, Single-Center, Open-Label, Pharmacodynamic Clinical Trial to Evaluate the Effect of Technosphere® Insulin Inhalation Powder Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Postprandial Glucose Levels in Subjects With Type 1 and Type 2 Diabetes Mellitus Ingesting Meals With Varied Carbohydrate Content

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Mannkind Corporation · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.

Conditions

Interventions

TypeNameDescription
DRUGTI Inhalation Powder and Humalog (Amendment 1)Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol.
DRUGTI Inhalation Powder (original protocol)Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics

Timeline

Start date
2008-09-01
Primary completion
2011-02-01
Completion
2011-05-01
First posted
2008-09-04
Last updated
2014-10-30
Results posted
2014-10-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00747006. Inclusion in this directory is not an endorsement.