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

MannKind

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Technosphere® Insulin

Drug: Technosphere Powder

Study type

Interventional

Funder types

Industry

Identifiers

NCT01451398

MKC-TI-175

Affinity2

Details and patient eligibility

About

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.

Enrollment

353 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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