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

This study has been completed.
Information provided by (Responsible Party):
Mannkind Corporation Identifier:
First received: October 7, 2011
Last updated: October 9, 2014
Last verified: October 2014
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 Intervention Phase
Type 2 Diabetes
Drug: Technosphere® Insulin
Drug: Technosphere Powder
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Mannkind Corporation:

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

  • 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

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

  • Proportion of Subjects Requiring Rescue Therapy [ Time Frame: 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

  • 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

  • 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.

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

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

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

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

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

Enrollment: 353
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01451398

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Sponsors and Collaborators
Mannkind Corporation
  More Information

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
Study First Received: October 7, 2011
Results First Received: July 22, 2014
Last Updated: October 9, 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 processed this record on May 25, 2017