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Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

NCT00309244 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 677

Last updated 2014-10-16

Study results available
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Summary

The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

Conditions

  • Diabetes Type 2

Interventions

DRUG

Technosphere® Insulin Inhalation Powder

Inhalation, 15U/30U

DRUG

70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-08-31
Completion
2008-09-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Mexico
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

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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 NCT00309244 on ClinicalTrials.gov