Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
NCT ID: NCT01445951
Last Updated: 2014-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
518 participants
INTERVENTIONAL
2011-09-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Technosphere® Insulin with MedTone C Inhaler
Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry
Technosphere® Insulin with MedTone C Inhaler
Inhalation Powder and injectable insulin
Aspart Group
Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry
Insulin Aspart in combination with a basal insulin
Injectable insulin
Technosphere ® Insulin-Gen2 Group
Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry
Technosphere ®Insulin with Gen2 Inhaler
Inhalation Powder and injectable insulin
Interventions
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Technosphere® Insulin with MedTone C Inhaler
Inhalation Powder and injectable insulin
Technosphere ®Insulin with Gen2 Inhaler
Inhalation Powder and injectable insulin
Insulin Aspart in combination with a basal insulin
Injectable insulin
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of type 1 diabetes mellitus for at least 12 months
* Body mass index (BMI) = 38 kg/m2
* Stable dose of basal/bolus insulin therapy for at least 3 months with an FPG consistently \< 220 mg/dL:
* HbA1c = 7.5% and = 10.0%
* Fasting C-peptide = 0.30 pmol/mL
* Subject willingness to not use CGM during the entire course of the trial
* Nonsmoking (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding 6 months
* Negative urine cotinine test, defined as = 100 ng/mL
* Lung function tests: • Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
* Written informed consent
Exclusion Criteria
* History of inhaled insulin use in the previous 6 months
* Two or more unexplained severe hypoglycemic episodes within 3 months of Screening or an episode of severe hypoglycemia between Visit 1 and Visit 2. Unexplained refers to episodes of severe hypoglycemia that are not related to a dosing error, lack of or a change in meal size, or related to additional/unanticipated exercise
* Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening, or hospitalization or emergency room visit due to poor diabetic control between Visit 1 and Visit 2
* Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the study, or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure
* History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements.
* History of COPD, asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis), or use of any medications for these conditions
* Any clinically significant radiological findings on screening chest x-ray
* Active respiratory infection within 30 days before Screening (subject may return after 30 days from resolution for rescreening)
* Major organ system diseases, including: ? Seizure disorder; systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine; cancer (other than excised cutaneous basal cell carcinoma) or any history of lung neoplasms
* Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity; use of medications for weight loss (eg, sibutramine, orlistat) within 12 weeks of Screening; treatment with amiodarone within 12 weeks of Screening
* Clinically significant abnormalities on screening laboratory evaluation or chest x-ray
* 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; nontraumatic amputations due to gangrene; or vascular claudication
* Women who are pregnant, lactating, or planning to become pregnant during the clinical study period; women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for this study includes amenorrhea f
* Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the PI, would make the subject an unsuitable candidate for participation in the study
* Exposure to any investigational medications or devices within the previous 30 days before study entry
* Unable to read or write, or unlikely to comprehend and follow the study protocol procedures; lack of compliance with medication or procedures that, in the PI's opinion, may affect the study data or subject safety and that precludes the subject from participation in the study; or any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical study or could limit the validity of the informed consent or impair the subject'
18 Years
ALL
No
Sponsors
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Mannkind Corporation
INDUSTRY
Responsible Party
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Locations
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Burlingame, California, United States
Escondido, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
La Mesa, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
San Mateo, California, United States
Santa Barbara, California, United States
Tustin, California, United States
Aurora, Colorado, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Palm Harbor, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Dunwoody, Georgia, United States
Lawrenceville, Georgia, United States
Roswell, Georgia, United States
Chicago, Illinois, United States
Vincennes, Indiana, United States
Des Moines, Iowa, United States
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Edina, Minnesota, United States
City of Saint Peters, Missouri, United States
Jefferson City, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Paramus, New Jersey, United States
Albuquerque, New Mexico, United States
Flushing, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Greenville, North Carolina, United States
Morehead City, North Carolina, United States
Portland, Oregon, United States
Greer, South Carolina, United States
Bartlett, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Federal Way, Washington, United States
Renton, Washington, United States
Wenatchee, Washington, United States
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Saint Petersburg, Russia, Russia
Saint Petersburg, Russia, Russia
Kemerovo, RUS, Russia
Moscow, RUS, Russia
Moscow, RUS, Russia
Moscow, RUS, Russia
Moscow, RUS, Russia
Moscow, RUS, Russia
Moscow, RUS, Russia
Moscow, RUS, Russia
Moscow, RUS, Russia
Petrozavodsk, RUS, Russia
Saint Petersburg, RUS, Russia
Saint Petersburg, RUS, Russia
Saint Petersburg, RUS, Russia
Saint Petersburg, RUS, Russia
Saint Petersburg, RUS, Russia
Saint Petersburg, RUS, Russia
Smolensk, RUS, Russia
Yaroslavl, RUS, Russia
Yaroslavl, RUS, Russia
Dnipropetrovsk, UKR, Ukraine
Donetsk, UKR, Ukraine
Kharkiv, UKR, Ukraine
Kiev, UKR, Ukraine
Kiev, UKR, Ukraine
Kyiv, UKR, Ukraine
Odesa, UKR, Ukraine
Odesa, UKR, Ukraine
Vinnytsia, UKR, Ukraine
Countries
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References
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Seaquist ER, Blonde L, McGill JB, Heller SR, Kendall DM, Bumpass JB, Pompilio FM, Grant ML. Hypoglycaemia is reduced with use of inhaled Technosphere(R) Insulin relative to insulin aspart in type 1 diabetes mellitus. Diabet Med. 2020 May;37(5):752-759. doi: 10.1111/dme.14202. Epub 2019 Dec 19.
Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB; Affinity 1 Study Group. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015 Dec;38(12):2266-73. doi: 10.2337/dc15-0075. Epub 2015 Jul 15.
Other Identifiers
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MKC-TI-171
Identifier Type: -
Identifier Source: org_study_id
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