MedTrace Logo

Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

NCT01445951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2014-10-22

Study results available
· View outcomes & findings →

Summary

Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Technosphere® Insulin with MedTone C Inhaler

Inhalation Powder and injectable insulin

DRUG

Technosphere ®Insulin with Gen2 Inhaler

Inhalation Powder and injectable insulin

DRUG

Insulin Aspart in combination with a basal insulin

Injectable insulin

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • United States
  • Brazil
  • Russia
  • Ukraine

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 NCT01445951 on ClinicalTrials.gov