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: August 19, 2013
Last verified: June 2013
  Purpose

Insulin-naive subjects with Type 2 Diabetes Mellitus 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® Insulin Powder
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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 added to 1 - 3 stable OADs
Drug: Technosphere® Insulin
Technosphere® Insulin Inhalation Powder
Placebo Comparator: Technosphere® Insulin powder
technosphere powder (with no insulin) added to 1 - 3 stable OADs
Drug: Technosphere® Insulin Powder
Placebo Comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451398

  Show 76 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01451398     History of Changes
Other Study ID Numbers: MKC-TI-175, Affinity2
Study First Received: October 7, 2011
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014