Status:
COMPLETED
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Mannkind Corporation
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral an...
Eligibility Criteria
Inclusion
- HbA1c \> or = to 7.5% and \< or = to 10.0%
- Body mass index (BMI) \< or = to 45 kg/m2
- Non smoker for at least 6 months before Screening
- Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
- Currently receiving as diabetes treatment only metformin or 2 or more OADs and on stable doses for at least 3 months before enrollment
- Subjects receiving metformin must be on at least 1.5gm daily, or up to the maximum tolerated dose
- Subjects treated with a sulfonylurea must be on at least 50% of the total maximum approved dose for a given agent
- Subjects receiving a DPP-4 inhibitor must receive the maximum approved dose specific for that agent
- Metiglinide and alpha-glucoside inhibitors must be taken at the highest tolerated dose within the approved dose range
- No previous or current treatment with insulin, except during an acute illness, gestational diabetes, or at time of initial diagnosis of diabetes
- Forced expiratory volume in one second (FEV1) \> or = to 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
- Forced vital capacity (FVC) \> or = to 70% NHANES III predicted
- Forced expiratory volume in one second as a percentage of forced vital capacity (FEV1/FVC) \> or = to NHANES III lower limit of normal (LLN)
Exclusion
- History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
- Any clinically significant radiological findings on screening chest x-ray
- Use of medications for asthma, COPD, or any other chronic respiratory conditions
- Evidence of serious complications of diabetes (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the Gen2C inhaler difficult)
- Renal disease or renal dysfunction
- Significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease
- Previous or current use of amiodarone
- Treatment with glucagon-like peptide-1 (GLP-1) analogs, thiazolidinediones (TZD), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening
- History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening
- History of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect HbA1c measurements
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT01451398
Start Date
November 1 2011
End Date
July 1 2013
Last Update
October 17 2014
Active Locations (76)
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1
Anaheim, California, United States, 92807
2
Huntington Beach, California, United States, 92648
3
Laguna Hills, California, United States, 92653
4
Long Beach, California, United States, 90806