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

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Technosphere® Insulin Inhalation Powder
Insulin Aspart
Insulin Glargine
Sponsored by
Mannkind Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Coastal Clinical Research Inc
  • Valley Research
  • Health Care Partners Medical Group
  • Diabetes Research Center
  • Diablo Clinical Research
  • Laureate Clinical Research Group
  • Atlanta Diabetes Associates
  • Alta Pharmaceutical Research Center
  • John H Stoger Jr Hospital of Cook County
  • LaPorte County Institute for Clinical Research Inc.
  • Radiant Research Inc (Minneapolis)
  • Amin Radparvar's Private Practice
  • Washington University School of Medicine
  • Billings Clinic Research Center
  • Creighton Diabetes Center
  • University of New Mexico HCS
  • Winthrop University Hospital
  • North Shore Diabetes and Endocrine Associates
  • Endocrine Research Physicians East PA
  • Your Diabetes Endocrine Nutrition Group, Inc.
  • Legacy Clinical Research
  • OHSU Diabetes Center Research Oregon Health & Science University
  • The Endocrine Clinic
  • Dallas Diabetes & Endocrine Center
  • Baylor Endocrine Center
  • University of Texas Southwestern Medical Center
  • SAM Clinical Research Center
  • Exodus Healthcare Network
  • Diabetes Research Center -Fletcher Allen Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Technosphere® Insulin Inhalation Powder (TI)

Comparator

Arm Description

Insulin Glargine and Technosphere® Insulin Inhalation Powder

Insulin Glargine and Insulin Aspart

Outcomes

Primary Outcome Measures

Change in HbA1c (%) From Baseline to Week 16
Change from Baseline in glycated hemoglobin at Week 16

Secondary Outcome Measures

To Evaluate the Effect of Each Treatment on HbA1c
Not analyzed due to early termination of the trial.
Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study
Not analyzed due to early termination of the trial.
Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study
Not analyzed due to early termination of the trial.
Glycomark and Fructosamine Levels Measured Throughout the Study
Not analyzed due to early termination of the trial.
Seven-point Glucose at Randomization and Throughout the Study
Not analyzed due to early termination of the trial.
Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)
Not analyzed due to early termination of the trial.
Changes in Body Weight at 16 Weeks
Not analyzed due to early termination of the trial.
Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires
Not analyzed due to early termination of the trial.
Total Number of Cough Episodes
Total number of times patients coughed once, intermittently or continuously (inclusive)
Severe Hypoglycemic Event Rate
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
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
Number of Subjects Reporting Cough Episodes
Number of Subjects Reporting Intermittent Coughing Episodes
Number of subjects reporting Intermittent Coughing Episodes
Number of Single Coughing Episodes
Total number of times patients coughed only once
Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation
Baseline Forced Expiratory Volume in 1 Second (FEV1)
Baseline FEV1
Week 16 Forced Expiratory Volume in 1 Second
Week 16 FEV1
Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second
Week 16 Change from Baseline in FEV1
Week 20 (Follow-up) Forced Expiratory Volume in 1 Second
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
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1
Baseline Forced Vital Capacity (FVC)
Baseline FVC
Week 16 Forced Vital Capacity
Week 16 FVC
Week 16 Change From Baseline Forced Vital Capacity
Week 16 Change from Baseline FVC
Week 20 (Follow-up) Forced Vital Capacity
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC
Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC

Full Information

First Posted
August 30, 2010
Last Updated
October 21, 2014
Sponsor
Mannkind Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01196104
Brief Title
Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
For Business Reasons
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Technosphere® Insulin Inhalation Powder (TI)
Arm Type
Experimental
Arm Description
Insulin Glargine and Technosphere® Insulin Inhalation Powder
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Insulin Glargine and Insulin Aspart
Intervention Type
Drug
Intervention Name(s)
Technosphere® Insulin Inhalation Powder
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart
Intervention Description
Usual Care
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Primary Outcome Measure Information:
Title
Change in HbA1c (%) From Baseline to Week 16
Description
Change from Baseline in glycated hemoglobin at Week 16
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
To Evaluate the Effect of Each Treatment on HbA1c
Description
Not analyzed due to early termination of the trial.
Time Frame
Change from baseline to 16 weeks
Title
Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study
Description
Not analyzed due to early termination of the trial.
Time Frame
Change from baseline to 16 weeks
Title
Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study
Description
Not analyzed due to early termination of the trial.
Time Frame
Change from baseline to 16 weeks
Title
Glycomark and Fructosamine Levels Measured Throughout the Study
Description
Not analyzed due to early termination of the trial.
Time Frame
Change from baseline to 16 weeks
Title
Seven-point Glucose at Randomization and Throughout the Study
Description
Not analyzed due to early termination of the trial.
Time Frame
Change from baseline to 16 weeks
Title
Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)
Description
Not analyzed due to early termination of the trial.
Time Frame
Change from baseline to 16 weeks
Title
Changes in Body Weight at 16 Weeks
Description
Not analyzed due to early termination of the trial.
Time Frame
Change from baseline to 16 weeks
Title
Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires
Description
Not analyzed due to early termination of the trial.
Time Frame
Change from baseline to 16 weeks
Title
Total Number of Cough Episodes
Description
Total number of times patients coughed once, intermittently or continuously (inclusive)
Time Frame
Baseline to Week 16
Title
Severe Hypoglycemic Event Rate
Description
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
Time Frame
Baseline to Week 16
Title
Mild or Moderate Hypoglycemic Event Rate
Description
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
Time Frame
Baseline to Week 16
Title
Number of Subjects Reporting Cough Episodes
Description
Number of Subjects Reporting Cough Episodes
Time Frame
Baseline to Week 16
Title
Number of Subjects Reporting Intermittent Coughing Episodes
Description
Number of subjects reporting Intermittent Coughing Episodes
Time Frame
Baseline to Week 16
Title
Number of Single Coughing Episodes
Description
Total number of times patients coughed only once
Time Frame
Baseline to Week 16
Title
Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation
Time Frame
Baseline to Week 16
Title
Baseline Forced Expiratory Volume in 1 Second (FEV1)
Description
Baseline FEV1
Time Frame
Baseline
Title
Week 16 Forced Expiratory Volume in 1 Second
Description
Week 16 FEV1
Time Frame
Week 16
Title
Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second
Description
Week 16 Change from Baseline in FEV1
Time Frame
Baseline to Week 16
Title
Week 20 (Follow-up) Forced Expiratory Volume in 1 Second
Description
Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment
Time Frame
Week 20 (Follow-up)
Title
Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second
Description
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1
Time Frame
Baseline to Week 20
Title
Baseline Forced Vital Capacity (FVC)
Description
Baseline FVC
Time Frame
Baseline
Title
Week 16 Forced Vital Capacity
Description
Week 16 FVC
Time Frame
Week 16
Title
Week 16 Change From Baseline Forced Vital Capacity
Description
Week 16 Change from Baseline FVC
Time Frame
Baseline to Week 16
Title
Week 20 (Follow-up) Forced Vital Capacity
Description
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC
Time Frame
Week 20
Title
Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity
Description
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC
Time Frame
Baseline to Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Coastal Clinical Research Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Health Care Partners Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Diabetes Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Laureate Clinical Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Alta Pharmaceutical Research Center
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
John H Stoger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
LaPorte County Institute for Clinical Research Inc.
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Radiant Research Inc (Minneapolis)
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Amin Radparvar's Private Practice
City
St Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
University of New Mexico HCS
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
North Shore Diabetes and Endocrine Associates
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Endocrine Research Physicians East PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Your Diabetes Endocrine Nutrition Group, Inc.
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Legacy Clinical Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
OHSU Diabetes Center Research Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Endocrine Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Dallas Diabetes & Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baylor Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
SAM Clinical Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Exodus Healthcare Network
City
Magna
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
Facility Name
Diabetes Research Center -Fletcher Allen Health Care
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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