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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01451398
Recruitment Status : Completed
First Posted : October 13, 2011
Results First Posted : October 17, 2014
Last Update Posted : October 17, 2014
Information provided by (Responsible Party):
Mannkind Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Technosphere® Insulin Drug: Technosphere Powder Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Proportion of Responders Achieving HbA1c <= 7.0% [ Time Frame: Week 24 ]
    Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%

  2. 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

  3. FPG Change From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
    Efficacy as measured by mean change in fasting plasma glucose (FPG)

  4. Proportion of Subjects Requiring Rescue Therapy [ Time Frame: Baseline to Week 24 ]
  5. 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

  6. 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

  7. 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.

  8. Incidence of Severe Hypoglycemia [ Time Frame: Baseline to Week 24 ]
    Severe Hypoglycemia defined as: Requiring 3rd party assistance.

  9. Total Hypoglycemia Event Rate [ Time Frame: Baseline to Week 24 ]
    Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

  10. Severe Hypoglycemia Event Rate [ Time Frame: Baseline to Week 24 ]
    Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)

  11. Mean 7-point Glucose Baseline Values [ Time Frame: Baseline ]
    Mean 7-point self-monitored glucose at baseline

  12. Mean 7-point Glucose Week 24 Values [ Time Frame: Week 24 ]
    Mean 7-point self-monitored blood glucose at Week 24

  13. Change in Body Weight From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
    Change in body weight from Baseline to Week 24

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01451398

  Hide Study Locations
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
United States, Florida
Hialeah, Florida, United States, 33012
Hollywood, Florida, United States, 33021
Miami, Florida, United States, 33156
Miami, Florida, United States, 33173
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
United States, 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
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Louisiana
Baton Rouge, Louisiana, United States, 70808
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, 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
United States, Nebraska
Omaha, Nebraska, United States, 68114
Omaha, Nebraska, United States, 68131
United States, New Jersey
Clifton, New Jersey, United States, 07012
Hackensack, New Jersey, United States, 07601
Paramus, New Jersey, United States, 07652
United States, New York
Flushing, New York, United States, 11365
New Hyde, New York, United States, 11042
United States, North Carolina
Greenville, North Carolina, United States, 27834
United States, Ohio
Perrysburg, Ohio, United States, 43551
United States, Oregon
Portland, Oregon, United States, 97239
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Arlington, Texas, United States, 76014
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77095
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78249
United States, Utah
Magna, Utah, United States, 84044
United States, Washington
Renton, Washington, United States, 98057
Wenatchee, Washington, United States, 98801
Porto Alegre, Brazil, 90035
Sao Paulo, Brazil, 01244
Russian Federation
Kemerovo, Russian Federation, 650066
Leningrad Region, Russian Federation
Moscow, Russian Federation, 105120
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 119435
Moscow, Russian Federation, 119991
Moscow, Russian Federation, 121374
Moscow, Russian Federation, 129128
Moscow, Russian Federation, 143420
Petrozavodsk, Russian Federation, 185019
Smolensk, Russian Federation, 214018
St. Petersburg, Russian Federation, 194044
St. Petersburg, Russian Federation, 194354
St. Petersburg, Russian Federation, 195257
St. Petersburg, Russian Federation, 196601
St. Petersburg, Russian Federation, 198013
Yaroslavl, Russian Federation, 150003
Yaroslavl, Russian Federation, 150023
Kharkiv, UKR, Ukraine, 61070
Kiev, UKR, Ukraine, 04053
Kyiv, UKR, Ukraine, 02175
Odesa, UKR, Ukraine, 65039
Vinnytsya, UKR, Ukraine, 21010
Kiev, Ukraine, 04114
Sponsors and Collaborators
Mannkind Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mannkind Corporation Identifier: NCT01451398     History of Changes
Other Study ID Numbers: MKC-TI-175
First Posted: October 13, 2011    Key Record Dates
Results First Posted: October 17, 2014
Last Update Posted: October 17, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs