Clinical Trials/NCT01196104

NCT01196104

Terminated

Phase 3

A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period

Mannkind Corporation29 sites in 1 country39 target enrollmentSeptember 2010

ConditionsType 2 Diabetes

InterventionsTechnosphere® Insulin Inhalation Powder Insulin Glargine Insulin Aspart

DrugsTechnosphere® Insulin Inhalation Powder Insulin Aspart Insulin Glargine

Overview

Phase: Phase 3
Intervention: Technosphere® Insulin Inhalation Powder
Conditions: Type 2 Diabetes
Sponsor: Mannkind Corporation
Enrollment: 39
Locations: 29
Primary Endpoint: Change in HbA1c (%) From Baseline to Week 16
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.

Detailed Description

Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

March 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mannkind Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women ≥ 18 and ≤ 80 years of age
•Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
•Body mass index (BMI) ≤ 45 kg/m2
•Glycated Hemoglobin (HbA1c) \> 6.5% and ≤ 10.0%
•Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry
•Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months
•Office spirometry at the investigator site
•Forced expiratory volume in 1 second (FEV1) ≥ 65% Third National Health and Nutrition Examination Survey (NHANES III) predicted
•Forced vital capacity (FVC) ≥ 65% NHANES III predicted
•Forced expiratory volume in 1 second as a percentage of forced vital capacity (FEV1/FVC) ≥ lower limit of normal (LLN)

Exclusion Criteria

Not provided

Arms & Interventions

Technosphere® Insulin Inhalation Powder (TI)

Insulin Glargine and Technosphere® Insulin Inhalation Powder

Intervention: Technosphere® Insulin Inhalation Powder

Comparator

Insulin Glargine and Insulin Aspart

Intervention: Insulin Glargine

Technosphere® Insulin Inhalation Powder (TI)

Insulin Glargine and Technosphere® Insulin Inhalation Powder

Intervention: Insulin Glargine

Comparator

Insulin Glargine and Insulin Aspart

Intervention: Insulin Aspart

Outcomes

Primary Outcomes

Change in HbA1c (%) From Baseline to Week 16

Time Frame: Baseline to Week 16

Change from Baseline in glycated hemoglobin at Week 16

Secondary Outcomes

Glycomark and Fructosamine Levels Measured Throughout the Study(Change from baseline to 16 weeks)
Seven-point Glucose at Randomization and Throughout the Study(Change from baseline to 16 weeks)
Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)(Change from baseline to 16 weeks)
Changes in Body Weight at 16 Weeks(Change from baseline to 16 weeks)
Week 20 (Follow-up) Forced Vital Capacity(Week 20)
To Evaluate the Effect of Each Treatment on HbA1c(Change from baseline to 16 weeks)
Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study(Change from baseline to 16 weeks)
Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study(Change from baseline to 16 weeks)
Total Number of Cough Episodes(Baseline to Week 16)
Severe Hypoglycemic Event Rate(Baseline to Week 16)
Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires(Change from baseline to 16 weeks)
Baseline Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
Week 20 (Follow-up) Forced Expiratory Volume in 1 Second(Week 20 (Follow-up))
Mild or Moderate Hypoglycemic Event Rate(Baseline to Week 16)
Week 16 Forced Expiratory Volume in 1 Second(Week 16)
Week 16 Change From Baseline Forced Vital Capacity(Baseline to Week 16)
Week 16 Forced Vital Capacity(Week 16)
Number of Subjects Reporting Cough Episodes(Baseline to Week 16)
Number of Subjects Reporting Intermittent Coughing Episodes(Baseline to Week 16)
Number of Single Coughing Episodes(Baseline to Week 16)
Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation(Baseline to Week 16)
Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second(Baseline to Week 16)
Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second(Baseline to Week 20)
Baseline Forced Vital Capacity (FVC)(Baseline)
Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity(Baseline to Week 20)