- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00700622
Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks
October 9, 2014 updated by: Mannkind Corporation
A Phase3, Multi-Center, Open-Label, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With Lantus® Versus Humalog® in Combination With Lantus® in Subjects With Type 1 Diabetes Mellitus Over a 16-Week Treatment Period
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sao Paulo, Brazil, 01244-030
- CPClin-Centro de Pesquisas Clinicas
-
-
RS
-
Porto Alegre, RS, Brazil, -90035-170
- Centro de Pesquisas em Diabetes Ltda
-
-
-
-
California
-
Huntington Beach, California, United States, 92648
- Diabetes/Lipid Management and Research Center
-
La Jolla, California, United States, 92037
- The Whittier Institute for Diabetes Clinical Trials
-
San Mateo, California, United States, 94401
- Dorothy L & James E Frank Diabetes Research Institute
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Barbara Davis Center for Diabetes Young Adult Clinic
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami School of Medicine
-
Miami, Florida, United States, 33136
- University of Miami Diabetes Research Institute
-
-
Georgia
-
Atlanta, Georgia, United States, 30309
- Atlanta Diabetes Associates
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112-2699
- Tulane University Health Sciences Center
-
-
Missouri
-
St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Montana
-
Billings, Montana, United States, 59101
- Deaconess Billings Clinic Research Center
-
-
North Carolina
-
Asheville, North Carolina, United States, 28803
- Mountain Diabetes & Endocrine Center
-
Greenville, North Carolina, United States, 27834
- Endocrine Research Physicians East PA
-
-
Ohio
-
Mentor, Ohio, United States, 44060
- Your Diabetes Endocrine Nutrition Group, Inc.
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Diabetes Center Research Oregon Health & Science University
-
-
Tennessee
-
Barrtlett, Tennessee, United States, 38133
- AM Diabetes And Endocrinology Center
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
-
Dallas, Texas, United States, 75246
- Baylor Endocrine Center
-
Dallas, Texas, United States, 75230
- Dallas Diabetes & Endocrine Center
-
-
Vermont
-
South Burlington, Vermont, United States, 05403
- Diabetes Research Center -Fletcher Allen Health Care
-
-
Washington
-
Seattle, Washington, United States, 98105
- Diabetes Care Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Clinically significant abnormalities on screening laboratory evaluation (unless discussed with and approved by the medical monitor)
- Women who were pregnant, lactating, or planning to become pregnant during the trial
- 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 was defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for this trial included amenorrhea for 2 or more years or surgically sterile
- 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 trial
- Exposure to any investigational medications or devices within 30 days before trial entry, or participation in another clinical trial while participating in this trial
- Unable or unlikely to comprehend and follow the trial protocol (including SBGM and diabetes education)
- Unable or unlikely to comprehend how to use the MedTone Inhaler or inability to use the device
- Unable or unlikely to follow a meal plan that included at least 2 meals/day (with or without a third meal or additional snacks)
- Noncompliance with medication or procedures that, in the PI's opinion, might affect the trial data or subject safety and that precluded the subject from further participation in the trial
- Any other concurrent medical or major psychiatric condition that, in the opinion of the PI, made the subject unsuitable for the clinical trial or could limit the validity of the informed consent or impair the subject's ability to participate in the trial
For the subset of subjects having Doppler echocardiograms:
- Subjects with left ventricular ejection fraction (LVEF) ≤ 35% at Visit 1
- Subjects with known history of sickle cell disease
- Previous use of Redux® (dexfenfluramine) or Pondimin® (fenfluramine)
- History of valvular heart disease, including mild or greater aortic insufficiency or moderate or greater mitral insufficiency
- Significant cardiovascular dysfunction or history within 12 months of Visit 1 (eg, congestive heart failure [NYHA Class III or IV]) or serious arrhythmia, treatment with medications to control or treat arrhythmias, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or cerebrovascular accident
- History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TI + Insulin glargine
Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
|
Technosphere Insulin Inhalation Powder 15U or 30U
|
Experimental: Insulin lispro + Insulin glargine
Humalog (insulin lispro) in combination with Lantus (insulin glargine)
|
Lantus-injectible supplied as 3mL (300 units) pens
Humalog autopen cartridges pre-filled with 3mL (300 units)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c to Week 16
Time Frame: Baseline to Week 16
|
Change from Baseline in glycosylated hemoglobin at Week 16
|
Baseline to Week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
June 16, 2008
First Submitted That Met QC Criteria
June 16, 2008
First Posted (Estimate)
June 18, 2008
Study Record Updates
Last Update Posted (Estimate)
October 16, 2014
Last Update Submitted That Met QC Criteria
October 9, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKC-TI-117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes, Type 1
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesTerminated
Clinical Trials on Technosphere Insulin
-
Mannkind CorporationCompleted
-
Mannkind CorporationCompletedType 2 Diabetes Mellitus
-
Mannkind CorporationCompleted
-
Mannkind CorporationCompletedType 2 DiabetesUnited States, Russian Federation, Brazil, Ukraine
-
Mannkind CorporationCompletedHealthy VolunteersUnited States
-
Mannkind CorporationCompletedDiabetes Mellitus, Type 2United States, Brazil, Spain, Argentina, Canada, Chile, Mexico, Poland, Russian Federation, Ukraine, Czech Republic
-
Mannkind CorporationCompleted
-
Mannkind CorporationCompletedType 1 Diabetes MellitusUnited States, Brazil, Russian Federation, Ukraine
-
Mannkind CorporationCompletedDiabetes Type 2Russian Federation
-
Mannkind CorporationCompletedDiabetes Mellitus | Upper Respiratory InfectionUnited States, Russian Federation, Canada