Skip to main content
OpenTrials
Completed

NCT Number: NCT01451398

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Porto Alegre, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technosphere® Insulin

Drug

Technosphere® Insulin Inhalation Powder

Technosphere Powder

Drug

Placebo Comparator

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 13, 2011
Registry last updated
Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.