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Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

This study has been terminated.
(For Business Reasons)
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01196104
First received: August 30, 2010
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
Drug: Technosphere® Insulin Inhalation Powder
Drug: Insulin Aspart
Drug: Insulin Glargine
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 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Change in HbA1c (%) From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    Change from Baseline in glycated hemoglobin at Week 16


Secondary Outcome Measures:
  • To Evaluate the Effect of Each Treatment on HbA1c [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
    Not analyzed due to early termination of the trial.

  • Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
    Not analyzed due to early termination of the trial.

  • Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
    Not analyzed due to early termination of the trial.

  • Glycomark and Fructosamine Levels Measured Throughout the Study [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
    Not analyzed due to early termination of the trial.

  • Seven-point Glucose at Randomization and Throughout the Study [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
    Not analyzed due to early termination of the trial.

  • Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM) [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
    Not analyzed due to early termination of the trial.

  • Changes in Body Weight at 16 Weeks [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
    Not analyzed due to early termination of the trial.

  • Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
    Not analyzed due to early termination of the trial.

  • Total Number of Cough Episodes [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]
    Total number of times patients coughed once, intermittently or continuously (inclusive)

  • Severe Hypoglycemic Event Rate [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]

    Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation

    Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:

    • SMBG levels ≤ 36 mg/dL OR
    • There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures

  • Mild or Moderate Hypoglycemic Event Rate [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]

    Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation

    Nonsevere hypoglycemia is defined as a subject:

    • SMBG levels < 70 mg/dL AND/OR
    • Symptoms that are relieved by the self-administration of carbohydrates

  • Number of Subjects Reporting Cough Episodes [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]
    Number of Subjects Reporting Cough Episodes

  • Number of Subjects Reporting Intermittent Coughing Episodes [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]
    Number of subjects reporting Intermittent Coughing Episodes

  • Number of Single Coughing Episodes [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]
    Total number of times patients coughed only once

  • Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]
  • Baseline Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Baseline FEV1

  • Week 16 Forced Expiratory Volume in 1 Second [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
    Week 16 FEV1

  • Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]
    Week 16 Change from Baseline in FEV1

  • Week 20 (Follow-up) Forced Expiratory Volume in 1 Second [ Time Frame: Week 20 (Follow-up) ] [ Designated as safety issue: Yes ]
    Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment

  • Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second [ Time Frame: Baseline to Week 20 ] [ Designated as safety issue: Yes ]
    Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1

  • Baseline Forced Vital Capacity (FVC) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Baseline FVC

  • Week 16 Forced Vital Capacity [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
    Week 16 FVC

  • Week 16 Change From Baseline Forced Vital Capacity [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: Yes ]
    Week 16 Change from Baseline FVC

  • Week 20 (Follow-up) Forced Vital Capacity [ Time Frame: Week 20 ] [ Designated as safety issue: Yes ]
    Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC

  • Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity [ Time Frame: Baseline to Week 20 ] [ Designated as safety issue: Yes ]
    Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC


Enrollment: 39
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Technosphere® Insulin Inhalation Powder (TI)
Insulin Glargine and Technosphere® Insulin Inhalation Powder
Drug: Technosphere® Insulin Inhalation Powder Drug: Insulin Glargine
Active Comparator: Comparator
Insulin Glargine and Insulin Aspart
Drug: Insulin Aspart
Usual Care
Drug: Insulin Glargine

Detailed Description:

Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 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 to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥ 18 and ≤ 80 years of age
  • Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
  • Body mass index (BMI) ≤ 45 kg/m2
  • Glycated Hemoglobin (HbA1c) > 6.5% and ≤ 10.0%
  • Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry
  • Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months
  • Office spirometry at the investigator site

    • Forced expiratory volume in 1 second (FEV1) ≥ 65% Third National Health and Nutrition Examination Survey (NHANES III) predicted
    • Forced vital capacity (FVC) ≥ 65% NHANES III predicted
    • Forced expiratory volume in 1 second as a percentage of forced vital capacity (FEV1/FVC) ≥ lower limit of normal (LLN)

Exclusion criteria:

  • Current or prior treatment with prandial or PreMix (70/30) insulin
  • History of insulin pump use within 6 weeks of Visit 1
  • Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
  • History of chronic obstructive pulmonary disease (COPD), 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 (eg, symptomatic autonomic neuropathy)
  • Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure [New York Heart Association {NYHA} Class III or IV])
  • Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident
  • History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196104

  Show 29 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01196104     History of Changes
Other Study ID Numbers: MKC-TI-162
Study First Received: August 30, 2010
Results First Received: July 22, 2014
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin Aspart
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014