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Status:

COMPLETED

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

Lead Sponsor:

Mannkind Corporation

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for \>or= to 6 months
  • Stable regimen of metformin for \> or = to 1000mg/day or maximum tolerated dose) and a secretagogue \< or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
  • Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
  • HbA1c \>or= to 7.5% and \< or= to 11.0%
  • BMI \< or = to 40kg/m2.
  • FEV1\> or = to 70%, Total Lung capacity and \> or =80% DLco \> or= to 70%

Exclusion

  • Treatment with any type of anti-diabetic therapy, other than metformin \& secretagogues within the preceding 12 weeks
  • Serum creatinine \> 1.4mg/dL in female subjects and \>1.5mg/dL in male subjects
  • History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
  • Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

Key Trial Info

Start Date :

December 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

547 Patients enrolled

Trial Details

Trial ID

NCT00332488

Start Date

December 1 2004

Last Update

October 16 2014

Active Locations (120)

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Page 1 of 30 (120 locations)

1

Radiant Research-Birmingham

Birmingham, Alabama, United States, 35209

2

Parkway Medical Center

Birmingham, Alabama, United States, 35215

3

Redpoint Research

Phoenix, Arizona, United States, 85029

4

Arizona Center for Clinical Research

Phoenix, Arizona, United States, 85032