Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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 anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.

Key facts

Study ID

NCT01451398

Run by

Mannkind Corporation

People needed

353

Starts

2011-11-01

Expected to finish

2013-07-01

Last updated by the study team

2014-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Huntington Beach, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — Tustin, California, United States
• Study site — West Hills, California, United States
• Study site — Hialeah, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Dunwoody, Georgia, United States
• Study site — Lawrenceville, Georgia, United States
• Study site — Roswell, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Edina, Minnesota, United States
• Study site — Anaheim, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.