Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease

NCT ID: NCT00642616

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-11-30

Brief Summary

Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary safety

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Moderate Chronic Obstructive Pulmonary Disease; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Technosphere® Insulin (Asthma)

Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Asthma

Group Type: EXPERIMENTAL

Technosphere® Insulin

Intervention Type: DRUG

Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents

Usual Care (Asthma)

Usual anti diabetic care in Diabetic participants with Asthma

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: DRUG

Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin

Technosphere® Insulin (COPD)

Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)

Group Type: EXPERIMENTAL

Technosphere® Insulin

Intervention Type: DRUG

Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents

Usual Care (COPD)

Usual anti diabetic care in Diabetic participants with Chronic Obstructive Pulmonary disease (COPD)

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: DRUG

Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin

Interventions

Technosphere® Insulin

Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents

Intervention Type: DRUG

Usual Care

Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin

Intervention Type: DRUG

Other Intervention Names

Afrezza

Eligibility Criteria

Inclusion Criteria

Asthma

• Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime
• Never smoked or former smokers (= 6 months since cessation)
• ≥18 years of age
• Prebronchodilator Forced Expiratory Volume in 1sec (FEV1) ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥70% predicted (Miller)
• < 30% day-to-day variability in daily morning Peak expiratory Volume (PEF) during the 2-week run-in period
• Significant improvement in pre- to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 mL in FEV1 or Forced Vital Capacity [FVC]) at Screening/Visit 1 or documented significant improvement in pre- to postbronchodilator spirometry (as defined above) within past 12 months in subject's medical records or a documented positive methacholine challenge test within the past 12 months

COPD

• Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause
• Former smoker (≥ 6 months since cessation) with smoking history of ≥ 10 pack years
• ≥40 years of age
• Postbronchodilator FEV1/FVC ratio < 70%
• Postbronchodilator FEV1 ≥ 50% NHANES III predicted, total lung capacity (TLC) ≥ 80% predicted ITS, and DLco (unc) ≥ 50% predicted (Miller)

Both

• Clinical diagnosis of Type1 or 2 diabetes mellitus for ≥ 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening
• BMI of, < 39 kg/m2
• Urine cotinine level ≤ 100ng/dL
• Clinical diagnosis of obstructive lung disease
• HbA1C > 6.5% ≤ 11.5%

Exclusion Criteria

• History of pulmonary exacerbation within 8 weeks of screening/V1 or between V1 and V2
• Use of systemic corticosteroids or antibiotics for respiratory illness within 8 weeks of screening/V1 OR between V1 and V2
• Increase from baseline in the use of short-acting bronchodilator or short-acting anticholinergic agents, or the combination of the 2, by ≥6 puffs or ≥3 nebulizer treatments per day for ≥ 2 days
• Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs.
• Greater than 2 hospitalizations or ER or urgent care visits or required >3 courses of systemic steroid in the past 12 months for respiratory illness
• Use of Symlin® (pramlintide acetate) within the preceding 90 days
• Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Screening and Baseline
• Previous exposure to any inhaled insulin product
• Currently using an insulin delivery pump
• Requires significant change (define as initiation of a new medication or change in the dose or frequency of the controller medications) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 (Week -4) or between Visit 1 and Baseline/Visit 2
• Severe complications of diabetes mellitus, in the opinion of the PI or sub-investigator, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene; and/or vascular claudication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_CHAIR

Mannkind Corporation

Locations

Mission Hills, California, United States

San Diego, California, United States

Palm Harbor, Florida, United States

Flint, Michigan, United States

Morehead City, North Carolina, United States

Medford, Oregon, United States

Greenville, South Carolina, United States

Spartanburg, South Carolina, United States

Dallas, Texas, United States

Dallas, Texas, United States

Federal Way, Washington, United States

Tacoma, Washington, United States

Yaroslavl, RUS, Russia

Kemerovo, RU, Russia

Moscow, RU, Russia

Saint Petersburg, RU, Russia

Saint Petersburg, RU, Russia

Saint Petersburg, RU, Russia

Saint Petersburg, RU, Russia

Kiev, UA, Ukraine

Kyiv, UA, Ukraine

Countries

United States; Russia; Ukraine

Other Identifiers

MKC-TI-134

Identifier Type: -

Identifier Source: org_study_id