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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT00332488

Run by

Mannkind Corporation

People needed

547

Starts

2004-12-01

Last updated by the study team

2014-10-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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)

Where it is running

• Parkway Medical Center — Birmingham, Alabama, United States
• Redpoint Research — Phoenix, Arizona, United States
• Arizona Center for Clinical Research — Phoenix, Arizona, United States
• International Clinical Research Network — Chula Vista, California, United States
• National Jewish Medical & Research Center — Denver, Colorado, United States
• Creekside Endocrine Associates — Denver, Colorado, United States
• Jennifer Hone MD — Denver, Colorado, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Center for Diabetes & Endocrine Care — Hollywood, Florida, United States
• International Research Associates LLC — Miami, Florida, United States
• Cedar-Crosse Research Center — Chicago, Illinois, United States
• John H Stoger Jr Hospital of Cook County — Chicago, Illinois, United States
• Clintell Inc — Skokie, Illinois, United States
• James A Dicke MDPA — Towson, Maryland, United States
• East Coast Clinical Research Inc — Haverhill, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Michigan Institute of Medicine — Livonia, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Clayton Medical Research — St Louis, Missouri, United States
• Raidant Research-St Louis — St Louis, Missouri, United States
• Creighton Diabetes Center — Omaha, Nebraska, United States
• Lovelace Scientific Resources (Albuquerque) — Albuquerque, New Mexico, United States
• Winthrop University Hospital — Mineola, New York, United States
• North Shore Diabetes and Endocrine Associates — New Hyde Park, New York, United States
• Radiant Research-Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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