Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus

October 9, 2014 updated by: Mannkind Corporation

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere® Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period

Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.

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.

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.
353

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
      • Porto Alegre, Brazil, 90035
      • Sao Paulo, Brazil, 01244
  • Russian Federation
      • Kemerovo, Russian Federation, 650066
      • Leningrad Region, Russian Federation
      • Moscow, Russian Federation, 143420
      • Moscow, Russian Federation, 119991
      • Moscow, Russian Federation, 129128
      • Moscow, Russian Federation, 117036
      • Moscow, Russian Federation, 119435
      • Moscow, Russian Federation, 105120
      • Moscow, Russian Federation, 121374
      • Petrozavodsk, Russian Federation, 185019
      • Smolensk, Russian Federation, 214018
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 194044
      • St. Petersburg, Russian Federation, 198013
      • St. Petersburg, Russian Federation, 195257
      • St. Petersburg, Russian Federation, 196601
      • Yaroslavl, Russian Federation, 150003
      • Yaroslavl, Russian Federation, 150023
  • Ukraine
      • Kiev, Ukraine, 04114
    • UKR
      • Kharkiv, UKR, Ukraine, 61070
      • Kiev, UKR, Ukraine, 04053
      • Kyiv, UKR, Ukraine, 02175
      • Odesa, UKR, Ukraine, 65039
      • Vinnytsya, UKR, Ukraine, 21010
  • United States
    • California
      • Anaheim, California, United States, 92807
      • Huntington Beach, California, United States, 92648
      • Laguna Hills, California, United States, 92653
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90036
      • Los Gatos, California, United States, 95032
      • Tustin, California, United States, 92780
      • West Hills, California, United States, 91307
    • 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
      • North Miami Beach, Florida, United States, 33179
      • Pembroke Pines, Florida, United States, 33026
      • Pinellas Park, Florida, United States, 33781
      • 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, 60607
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
    • 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
      • St. Louis, Missouri, United States, 63117
    • Nebraska
      • Omaha, Nebraska, United States, 68114
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Clifton, New Jersey, United States, 07012
      • Hackensack, New Jersey, United States, 07601
      • Paramus, New Jersey, United States, 07652
    • New York
      • Flushing, New York, United States, 11365
      • New Hyde, New York, United States, 11042
    • North Carolina
      • Greenville, North Carolina, United States, 27834
    • Ohio
      • Perrysburg, Ohio, United States, 43551
    • Oregon
      • Portland, Oregon, United States, 97239
    • South Carolina
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Memphis, Tennessee, United States, 38119
    • 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
      • San Antonio, Texas, United States, 78249
    • Utah
      • Magna, Utah, United States, 84044
    • Washington
      • 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:

  • HbA1c > or = to 7.5% and < or = to 10.0%
  • Body mass index (BMI) < or = to 45 kg/m2
  • Non smoker for at least 6 months before Screening
  • Clinical diagnosis of type 2 diabetes mellitus for more than 12 months

  • Currently receiving as diabetes treatment only metformin or 2 or more OADs and on stable doses for at least 3 months before enrollment

    • Subjects receiving metformin must be on at least 1.5gm daily, or up to the maximum tolerated dose
    • Subjects treated with a sulfonylurea must be on at least 50% of the total maximum approved dose for a given agent
    • Subjects receiving a DPP-4 inhibitor must receive the maximum approved dose specific for that agent
    • Metiglinide and alpha-glucoside inhibitors must be taken at the highest tolerated dose within the approved dose range
  • No previous or current treatment with insulin, except during an acute illness, gestational diabetes, or at time of initial diagnosis of diabetes
  • Forced expiratory volume in one second (FEV1) > or = to 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
  • Forced vital capacity (FVC) > or = to 70% NHANES III predicted
  • Forced expiratory volume in one second as a percentage of forced vital capacity (FEV1/FVC) > or = to NHANES III lower limit of normal (LLN)

Exclusion Criteria:

  • History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
  • Any clinically significant radiological findings on screening chest x-ray
  • Use of medications for asthma, COPD, or any other chronic respiratory conditions
  • Evidence of serious complications of diabetes (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the Gen2C inhaler difficult)
  • Renal disease or renal dysfunction
  • Significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease
  • Previous or current use of amiodarone
  • Treatment with glucagon-like peptide-1 (GLP-1) analogs, thiazolidinediones (TZD), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening
  • History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening
  • History of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect HbA1c measurements

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: Double

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: TI inhalation powder
Technosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs
Drug: Technosphere® Insulin
Technosphere® Insulin Inhalation Powder
Placebo Comparator: Technosphere powder
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs
Drug: Technosphere Powder
Placebo Comparator

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
Efficacy as measured by change in glycated hemoglobin (HbA1c) 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
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
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
Proportion of Responders Achieving HbA1c <= 6.5%
Time Frame: Week 24
Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% at Week 24
Week 24
FPG Change From Baseline to Week 24
Time Frame: Baseline to Week 24
Efficacy as measured by mean change in fasting plasma glucose (FPG)
Baseline to Week 24
Proportion of Subjects Requiring Rescue Therapy
Time Frame: Baseline to Week 24
Baseline to Week 24
Time to Rescue
Time Frame: Baseline to Week 24
Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment
Baseline to Week 24
Mean 7-point Glucose Baseline Values
Time Frame: Baseline
Mean 7-point self-monitored glucose at baseline
Baseline
Mean 7-point Glucose Week 24 Values
Time Frame: Week 24
Mean 7-point self-monitored blood glucose at Week 24
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.
November 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.
June 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.
July 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).
October 7, 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 12, 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 13, 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 17, 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 9, 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-175
  • Affinity2

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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