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

October 20, 2014 updated by: Mannkind Corporation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
518

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-170
    • SP
      • Sao Paulo, SP, Brazil, 01244-030
  • Russian Federation
    • RUS
      • Kemerovo, RUS, Russian Federation, 650066
      • Moscow, RUS, Russian Federation, 105120
      • Moscow, RUS, Russian Federation, 109240
      • Moscow, RUS, Russian Federation, 117036
      • Moscow, RUS, Russian Federation, 117593
      • Moscow, RUS, Russian Federation, 119048
      • Moscow, RUS, Russian Federation, 119435
      • Moscow, RUS, Russian Federation, 125299
      • Moscow, RUS, Russian Federation, 125315
      • Petrozavodsk, RUS, Russian Federation, 185019
      • Smolensk, RUS, Russian Federation, 214018
      • St Petersburg, RUS, Russian Federation, 194291
      • St Petersburg, RUS, Russian Federation, 195257
      • St Petersburg, RUS, Russian Federation, 198013
      • St. Petersburg, RUS, Russian Federation, 192148
      • St. Petersburg, RUS, Russian Federation, 194044
      • St. Petersburg, RUS, Russian Federation, 194354
      • Yaroslavl, RUS, Russian Federation, 150003
      • Yaroslavl, RUS, Russian Federation, 150062
    • Russia
      • St. Petersburg, Russia, Russian Federation, 191186
      • St. Petersburg, Russia, Russian Federation, 193312
  • Ukraine
    • UKR
      • 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, 65039
      • Odesa, UKR, Ukraine, 65114
      • Vinnytsya, UKR, Ukraine, 21010
  • 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
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Hialeah, Florida, United States, 33012
      • Hollywood, Florida, United States, 33021
      • Miami, Florida, United States, 33173
      • Miami, Florida, United States, 33156
      • New Port Richey, Florida, United States, 34652
      • Palm Harbor, Florida, United States, 34652
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30318
      • Dunwoody, Georgia, United States, 30338
      • Lawrenceville, Georgia, United States, 30045
      • Roswell, Georgia, United States, 30076
    • Illinois
      • Chicago, Illinois, United States, 60602
    • Indiana
      • Vincennes, Indiana, United States, 47591
    • Iowa
      • Des Moines, Iowa, United States, 50314
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
      • Metairie, Louisiana, United States, 70006
      • New Orleans, Louisiana, United States, 70112
    • Minnesota
      • Edina, Minnesota, United States, 55435
    • Missouri
      • Jefferson City, Missouri, United States, 65109
      • St Peters, Missouri, United States, 63376
      • St. Louis, Missouri, United States, 63110
    • Montana
      • Billings, Montana, United States, 59101
    • Nebraska
      • Omaha, Nebraska, United States, 68114
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Paramus, New Jersey, United States, 07652
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Flushing, New York, United States, 11365
      • New Hyde Park, New York, United States, 11042
      • New York, New York, United States, 10016
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Greenville, North Carolina, United States, 27834
      • Morehead City, North Carolina, United States, 28557
    • Oregon
      • Portland, Oregon, United States, 97239
    • South Carolina
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
    • 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
    • Utah
      • Murray, Utah, United States, 84123
    • Washington
      • Federal Way, Washington, United States, 98003
      • Renton, Washington, United States, 98057
      • Wenatchee, Washington, United States, 98801

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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'

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 24 in HbA1c
Time Frame: Baseline to Week 24
Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24
Baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FEV1 Change From Baseline to Week 24
Time Frame: Baseline to Week 24
Forced Expiratory Volume in 1 second - change from baseline to week 24
Baseline to Week 24
FPG Change From Baseline to Week 24
Time Frame: Baseline to Week 24
Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)
Baseline to Week 24
Mean 7-point Glucose Baseline Values
Time Frame: Baseline
Mean 7-point glucose at baseline
Baseline
Mean 7-point Glucose Week 24 Values
Time Frame: Week 24
Week 24
Change in Body Weight From Baseline to Week 24
Time Frame: Baseline to Week 24
Change in body weight from Baseline to Week 24
Baseline to Week 24
Proportion of Responders Achieving HbA1c <= 7.0%
Time Frame: Week 24
Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%
Week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Total Hypoglycemia
Time Frame: Baseline to Week 24
Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.
Baseline to Week 24
Incidence of Severe Hypoglycemia
Time Frame: Baseline to Week 24
Severe Hypoglycemia defined as: Requiring 3rd party assistance.
Baseline to Week 24
Total Hypoglycemia Event Rate
Time Frame: Baseline to Week 24
Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
Baseline to Week 24
Severe Hypoglycemia Event Rate
Time Frame: Baseline to Week 24
Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mannkind Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MKC-TI-171

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.

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