Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

Stopped early · Phase 3

Conditions studied: Diabetes, Type 1

In brief

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Key facts

Study ID

NCT00700622

Run by

Mannkind Corporation

People needed

130

Starts

2008-05-01

Expected to finish

2010-03-01

Last updated by the study team

2014-10-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women ≥ 18 and ≤ 80 years old
• Clinical diagnosis of type 1 diabetes mellitus for more than 12 months
• Body mass index (BMI) ≤ 30 kg/m2
• Stable antidiabetic regimen of sc insulin therapy at a total daily dose ≤ 1.5 IU/kg/day
• HbA1c > 7.0% and ≤ 9.0%
• C-peptide level ≤ 0.30 pmol/mL
• Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for at least the preceding 6 months
• Negative urine cotinine defined as ≤ 100 ng/mL
• Pulmonary function tests (PFTs):
• Forced expiratory volume in 1 second (FEV1) ≥ 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
• FEV1 as a percentage of FEV1/forced vital capacity (FVC) ≥ 70% (NHANES III) predicted
• Total lung capacity (TLC) ≥ 80% predicted (Intermountain Thoracic Society [ITS])
• Single breath carbon monoxide diffusing capacity of the lung, hemoglobin-corrected (DLco-Hb) (uncorrected) ≥ 70% predicted
• For the subset of subjects having Doppler echocardiograms: right ventricular systolic pressure (RVSP) ≤ 40 mm Hg at Visit 1
• Written informed consent

You may not qualify if…

• Treatment with any type of antidiabetic drugs, other than sc insulin, within the preceding 12 weeks
• Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Visit 1 and Visit 5
• Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Visit 1, or hospitalization or emergency room visit due to poor diabetic control between Visit 1 and Visit 5
• Severe complications of diabetes, in the opinion of the PI, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant, or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene; or vascular claudication
• Previous exposure to an inhaled insulin product within 3 months of Visit 1
• History of insulin pump use within 6 weeks of Visit 1
• Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial, or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure
• Significant improvement in pre- to postbronchodilator spirometry at Visit 1 (defined as an increase of 12% and 200 mL in either FEV1 or FVC)
• History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, obstructive sleep apnea) confirmed by pulmonary function testing or radiologic findings
• Inability to perform spirometry maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria
• Active respiratory infection (subject could return after 30 days from resolution for rescreening); if respiratory infection manifested after Visit 1 but before Visit 1 PFTs, subject was to be scheduled for PFTs after 30 days from resolution of respiratory infection. An additional hemoglobin was to be required
• Major organ system diseases, including:
• Seizure disorder
• Significant cardiovascular dysfunction or history within 3 months of Visit 1, eg, congestive heart failure (New York Heart Association [NYHA] Class III or IV), or serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or cerebrovascular accident
• Uncontrolled hypertension with a systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg at Visit 1 despite pharmacologic treatment
• Nephrotic syndrome; renal dysfunction or disease; serum creatinine > 2.0 mg/dL (0.11 mmol/L) in men and > 1.8 mg/dL (0.1 mmol/L) in women; or blood urea nitrogen (BUN) > 50 mg/dL (2.8 mmol/L)
• Cancer (other than excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms
• History of active viral or cirrhotic hepatic disease or abnormal liver enzymes as evidenced by serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal (ULN)
• Active infection (eg, human immunodeficiency virus [HIV], hepatitis) or history of severe infection within 30 days of Visit 1
• Anemia (hemoglobin ≤ 10.5 g/dL for women or ≤ 11.5 g/dL for men)
• Diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
• Any concurrent illness, other than diabetes mellitus, not controlled by a stable therapeutic regimen
• Current or previous chemotherapy or radiation therapy that might result in pulmonary toxicity
• Use of medications prescribed for weight loss (eg, sibutramine, orlistat) within 12 weeks of Visit 1
• Any history of or current use of amiodarone

Where it is running

• Diabetes/Lipid Management and Research Center — Huntington Beach, California, United States
• The Whittier Institute for Diabetes Clinical Trials — La Jolla, California, United States
• Dorothy L & James E Frank Diabetes Research Institute — San Mateo, California, United States
• Barbara Davis Center for Diabetes Young Adult Clinic — Aurora, Colorado, United States
• University of Miami Diabetes Research Institute — Miami, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Deaconess Billings Clinic Research Center — Billings, Montana, United States
• Mountain Diabetes & Endocrine Center — Asheville, North Carolina, United States
• Endocrine Research Physicians East PA — Greenville, North Carolina, United States
• Your Diabetes Endocrine Nutrition Group, Inc. — Mentor, Ohio, United States
• OHSU Diabetes Center Research Oregon Health & Science University — Portland, Oregon, United States
• AM Diabetes and Endocrinology Center — Barrtlett, Tennessee, United States
• Dallas Diabetes & Endocrine Center — Dallas, Texas, United States
• Baylor Endocrine Center — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Diabetes Research Center -Fletcher Allen Health Care — South Burlington, Vermont, United States
• Diabetes Care Center — Seattle, Washington, United States
• Centro de Pesquisas em Diabetes Ltda — Porto Alegre, Rio Grande do Sul, Brazil
• CPClin-Centro de Pesquisas Clinicas — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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