Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01445951
First received: September 30, 2011
Last updated: August 19, 2013
Last verified: June 2013
  Purpose

Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Technosphere® Insulin with MedTone C Inhaler
Drug: Technosphere ®Insulin with Gen2 Inhaler
Drug: Insulin Aspart in combination with a basal insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With a Basal Insulin Versus Insulin Aspart in Combination With a Basal Insulin in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Effect of treatment as measured by change in glycated hemoglobin (HbA1c): Comparison of baseline HbA1c to end of treatment HbA1c after 24 weeks [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 changes from Baseline to the final treatment visit compared between TI-Gen2C and TI-MedTone C treatment groups [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Comparison of mean change from randomization visit to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Comparison of mean 7-point glucose from the week before the randomization visit to those measured the week before the Week 24 visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change in body weight from Randomization to the end of the treatment period [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 518
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Technosphere® Insulin with MedTone C Inhaler
Inhalation Powder and injectable insulin
Active Comparator: Aspart Group
Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry
Drug: Insulin Aspart in combination with a basal insulin
Injectable insulin
Experimental: 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
Drug: Technosphere ®Insulin with Gen2 Inhaler
Inhalation Powder and injectable insulin

Detailed Description:

Phase 3 clinical trial designed to examine the efficacy and safety of inhaled prandial TI Inhalation Power in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 diabetes who are suboptimally controlled with their current insulin regimens. This trial will employ a variety of methods to intensively manage these subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women = 18 years of age
  • 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:

  • Total daily insulin dose = 2 IU/kg/day. History of insulin pump use within 3 months of Screening or use of continuous glucose monitoring within 6 weeks of Screening
  • 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'
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01445951

  Hide Study Locations
Locations
United States, California
Burlingame, California, United States, 94010
Escondido, California, United States, 92026
Huntington Beach, California, United States, 92648
La Jolla, California, United States, 92037
La Mesa, California, United States, 91942
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90017
Los Gatos, California, United States, 95032
San Mateo, California, United States, 94401
Santa Barbara, California, United States, 93105
Tustin, California, United States, 92780
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Hialeah, Florida, United States, 33012
Hollywood, Florida, United States, 33021
Miami, Florida, United States, 33156
Miami, Florida, United States, 33173
New Port Richey, Florida, United States, 34652
Palm Harbor, Florida, United States, 34652
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta, Georgia, United States, 30318
Atlanta, Georgia, United States, 30308
Dunwoody, Georgia, United States, 30338
Lawrenceville, Georgia, United States, 30045
Roswell, Georgia, United States, 30076
United States, Illinois
Chicago, Illinois, United States, 60602
United States, Indiana
Vincennes, Indiana, United States, 47591
United States, Iowa
Des Moines, Iowa, United States, 50314
United States, Louisiana
Baton Rouge, Louisiana, United States, 70808
Metairie, Louisiana, United States, 70006
New Orleans, Louisiana, United States, 70112
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Missouri
Jefferson City, Missouri, United States, 65109
St Peters, Missouri, United States, 63376
St. Louis, Missouri, United States, 63110
United States, Montana
Billings, Montana, United States, 59101
United States, Nebraska
Omaha, Nebraska, United States, 68114
Omaha, Nebraska, United States, 68131
United States, New Jersey
Paramus, New Jersey, United States, 07652
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Flushing, New York, United States, 11365
New Hyde Park, New York, United States, 11042
New York, New York, United States, 10016
United States, North Carolina
Asheville, North Carolina, United States, 28803
Greenville, North Carolina, United States, 27834
Morehead City, North Carolina, United States, 28557
United States, Oregon
Portland, Oregon, United States, 97239
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Tennessee
Bartlett, Tennessee, United States, 38133
United States, Texas
Arlington, Texas, United States, 76014
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77095
San Antonio, Texas, United States, 78229
United States, Utah
Murray, Utah, United States, 84123
United States, Washington
Federal Way, Washington, United States, 98003
Renton, Washington, United States, 98057
Wenatchee, Washington, United States, 98801
Brazil
Porto Alegre, RS, Brazil, 90035-170
Sao Paulo, SP, Brazil, 01244-030
Russian Federation
St. Petersburg, Russia, Russian Federation, 193312
St. Petersburg, Russia, Russian Federation, 191186
Kemerovo, RUS, Russian Federation, 650066
Moscow, RUS, Russian Federation, 117036
Moscow, RUS, Russian Federation, 119048
Moscow, RUS, Russian Federation, 125315
Moscow, RUS, Russian Federation, 117593
Moscow, RUS, Russian Federation, 125299
Moscow, RUS, Russian Federation, 109240
Moscow, RUS, Russian Federation, 119435
Moscow, RUS, Russian Federation, 105120
Petrozavodsk, RUS, Russian Federation, 185019
Smolensk, RUS, Russian Federation, 214018
St Petersburg, RUS, Russian Federation, 194291
St Petersburg, RUS, Russian Federation, 198013
St Petersburg, RUS, Russian Federation, 195257
St. Petersburg, RUS, Russian Federation, 194044
St. Petersburg, RUS, Russian Federation, 194354
St. Petersburg, RUS, Russian Federation, 192148
Yaroslavl, RUS, Russian Federation, 150062
Yaroslavl, RUS, Russian Federation, 150003
Ukraine
Dnipropetrovsk, UKR, Ukraine, 49023
Donetsk, UKR, Ukraine, 83114
Kharkiv, UKR, Ukraine, 61070
Kiev, UKR, Ukraine, 04053
Kiev, UKR, Ukraine, 04114
Kyiv, UKR, Ukraine, 02175
Odesa, UKR, Ukraine, 65114
Odesa, UKR, Ukraine, 65039
Vinnytsya, UKR, Ukraine, 21010
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01445951     History of Changes
Other Study ID Numbers: MKC-TI-171
Study First Received: September 30, 2011
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014