Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mannkind Corporation
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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.
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 be 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)
