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Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

NCT00332488 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2014-10-16

Study results available
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Summary

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Technosphere Insulin

Inhalation, 15U/30U, prandial

DRUG

Metformin & Secretagogues

Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.

DRUG

Technosphere Insulin & Metformin

Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • For MannKind sponsored trials, the Overall Study Official is the Chief Scientific Officer · Mannkind Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-03-31

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Czechia
  • Mexico
  • Poland
  • Russia
  • Spain
  • Ukraine

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 NCT00332488 on ClinicalTrials.gov