MedTrace Logo

Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

NCT00700622 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-10-16

Study results available
· View outcomes & findings →

Summary

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Conditions

  • Diabetes, Type 1

Interventions

DRUG

Technosphere Insulin

Technosphere Insulin Inhalation Powder 15U or 30U

DRUG

Insulin glargine

Lantus-injectible supplied as 3mL (300 units) pens

DRUG

Insulin lispro

Humalog autopen cartridges pre-filled with 3mL (300 units)

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-11-30
Completion
2010-03-31

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00700622 on ClinicalTrials.gov