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

This study has been terminated.
(Terminated upon recommendation of the Data Safety Monitoring Board (DSMB))
Sponsor:
Collaborator:
Mannkind Corporation
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00642616
First received: March 21, 2008
Last updated: February 12, 2016
Last verified: February 2016

March 21, 2008
February 12, 2016
March 2009
November 2014   (final data collection date for primary outcome measure)
Change in Post-bronchodilator FEV1 From Baseline to Week 52 [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.
Comparison between the TI and UC Treatment Groups, with respect to change in post-bronchodilator FEV1 from Visit 1 to Final Visit. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00642616 on ClinicalTrials.gov Archive Site
  • Number of Participants With Asthma Exacerbation by Treatment Arm [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    Number of participants who experienced worsening of asthma symptoms
  • Number of Participants With COPD Exacerbation by Treatment Arm [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    Number of participants who experienced worsening of COPD symptoms
  • Change in HbA1C From Baseline to Week 52 [ Time Frame: Baseline, week 52 ] [ Designated as safety issue: No ]
Additional changes to lung function [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
A Phase 3, Open-label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder in Type 1 or Type 2 Diabetic Subjects With Obstructive Pulmonary Disease (Asthma or Chronic Obstructive Pulmonary Disease) Over a 12 Months Treatment Period With a 2 Month Follow-up
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
  • Moderate Chronic Obstructive Pulmonary Disease
  • Asthma
  • Drug: 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
    Other Name: Afrezza
  • 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
  • Experimental: Technosphere® Insulin (Asthma)
    Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Asthma
    Intervention: Drug: Technosphere® Insulin
  • Active Comparator: Usual Care (Asthma)
    Usual anti diabetic care in Diabetic participants with Asthma
    Intervention: Drug: Usual Care
  • Experimental: Technosphere® Insulin (COPD)
    Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
    Intervention: Drug: Technosphere® Insulin
  • Active Comparator: Usual Care (COPD)
    Usual anti diabetic care in Diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
    Intervention: Drug: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation,   Ukraine
Argentina,   Brazil,   Chile,   Germany,   Hungary,   Slovakia
 
NCT00642616
MKC-TI-134
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Mannkind Corporation
Study Chair: Chief Medical Officer Mannkind Corporation
Sanofi
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP