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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.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01451398
First received: October 7, 2011
Last updated: October 9, 2014
Last verified: October 2014

October 7, 2011
October 9, 2014
November 2011
June 2013   (final data collection date for primary outcome measure)
Change From Baseline to Week 24 in HbA1c [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24
Efficacy as measured by change in glycated hemoglobin (HbA1c) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01451398 on ClinicalTrials.gov Archive Site
  • Proportion of Responders Achieving HbA1c <= 7.0% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%
  • Proportion of Responders Achieving HbA1c <= 6.5% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Efficacy as measured by mean change in fasting plasma glucose (FPG)
  • Proportion of Subjects Requiring Rescue Therapy [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Time to Rescue [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Forced Expiratory Volume in 1 second - change from baseline to week 24
  • Incidence of Total Hypoglycemia [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Severe Hypoglycemia defined as: Requiring 3rd party assistance.
  • Total Hypoglycemia Event Rate [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
  • Severe Hypoglycemia Event Rate [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)
  • Mean 7-point Glucose Baseline Values [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Mean 7-point self-monitored glucose at baseline
  • Mean 7-point Glucose Week 24 Values [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in body weight from Baseline to Week 24
  • Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0% [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
  • Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
  • Efficacy as measured by mean change in fasting plasma glucose (FPG) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
  • Efficacy as measured in proportion of subjects requiring rescue therapy [ Time Frame: Measured from Week 0 (baseline) to time of rescue ] [ Designated as safety issue: No ]
  • Measure the incident and rate of hypoglycemia, cough and other adverse events (AEs) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
  • Measure the changes in anti-insulin immunoglobulin G titers [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
  • Changes in lung function [ Time Frame: Measured from Week 0 (baseline) to Week 28 (end of treatment - 24 weeks and 4 week follow up) ] [ Designated as safety issue: Yes ]
  • Measure the changes in vital signs, ECGs, clinical laboratory tests, lung function parameters (FEV1, FVC and FEV1/FVC ratio) and physical examination findings [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
  • Time to rescue [ Time Frame: 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Technosphere® Insulin
    Technosphere® Insulin Inhalation Powder
  • Drug: Technosphere Powder
    Placebo Comparator
  • Experimental: TI inhalation powder
    Technosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs
    Intervention: Drug: Technosphere® Insulin
  • Placebo Comparator: Technosphere powder
    Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs
    Intervention: Drug: Technosphere Powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
353
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Russian Federation,   Ukraine
 
NCT01451398
MKC-TI-175, Affinity2
Yes
Mannkind Corporation
Mannkind Corporation
Not Provided
Not Provided
Mannkind Corporation
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP