Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

This study has been terminated.
(For Business Reasons)
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01196104
First received: August 30, 2010
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: Technosphere® Inhalation (TI)
Drug: Insulin Aspart
Drug: Glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • To Demonstrate that the efficacy of Technosphere® Inhalation (TI) Inhalation Powder in combination with insulin glargine is noninferior to insulin aspart in combination with insulin [ Time Frame: Change in HbA1c from baseline to Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of each treatment on HbA1c [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Comparison of fasting plasma glucose (FPG) levels at randomization and throughout the study [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Comparison of post-prandial glucose (PPG) levels at randomization and throughout the study [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Glycomark and fructosamine levels measured throughout the study [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Seven-point glucose at randomization and throughout the study [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Glycemic excursions and variability as assessed through continuous glucose monitoring (CGM) [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Changes in body weight at 16 weeks [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Treatment satisfaction as assessed by subject treatment and health outcomes questionnaires [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Safety expressed as the incidence and rate of hypoglycemia, cough, other adverse events (AEs) and at selected sites in subsets of subjects, changes in pulmonary function and Doppler ECHO [ Time Frame: Change from baseline to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Technosphere® Inhalation (TI)
Glargine and Technosphere® Insulin Inhalation Powder
Drug: Technosphere® Inhalation (TI)
Inhalation Powder
Active Comparator: Comparator
Glargine and Insulin Aspart
Drug: Insulin Aspart
Usual Care
Drug: Glargine
In combination with Technosphere® Insulin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men & Women >18 and <80 years old
  • Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
  • (FEV1/FVC) > lower limit of normal (LLN)
  • Written informed consent
  • Treatment with 1 to 3 OADs and the use of basal insulins
  • Nonsmokers (includes cigarettes, cigars, pipes and chewing tobacco) for the preceding 6 months
  • Negative urine cotinine test, defined a <100 ng/mL
  • FEV1 >65%
  • FVC>65%
  • Body mass index (BMI) < 45kg/m2
  • HbA1c>6.5% and <9.0%

Exclusion Criteria:

  • Current or prior treatment with prandial or Pre-mix (70/30) insulin
  • History of insulin pump use within 6 weeks of Visit 1
  • Treatment with GLP-1 analog drugs within the preceding 12 weeks
  • Two or more unexplained severe hypoglycemic episodes within 3 months of screening
  • Severe complications of diabetes in the opinion of the PI, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant, or dialysis; nontraumatic amputations due to gangrene or vascular claudication
  • Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial, or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure.
  • History of COPD, asthma, or any other clinically important pulmonary disease
  • Any clinically significant radiological findings on screening chest X-ray
  • Use of medications for asthma, COPD, or any other chronic respiratory conditions
  • Inability to perform spirometry maneuvers meeting the recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria
  • Active respiratory infection within 30 days before Visit 1 (subject may return after 30 days from resolution for rescreening)
  • Major organ system diseases (seizure disorder, significant cardiovascular dysfunction, uncontrolled hypertension, pulmonary embolism or deep venous thrombosis, cancer, active infection, etc)
  • Any concurrent illness, other than diabetes mellitus, not controlled by stable therapeutic regimen
  • Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity
  • Use of medications for weight loss within 12 weeks of Visit 1
  • Any history of or current use of amiodarone
  • Clinically significant abnormalities on screening laboratory evaluation
  • Women who are pregnant, lactating, or planning to become pregnant during the clinical trial period
  • Women of childbearing potential not practicing adequate birth control
  • Current drug or alcohol abuse or a history of drug or alcohol abuse that in the opinion of the PI, would make the subject an unsuitable candidate for participation in the trial
  • Unable or unlikely to comprehend how to use the Gen2 inhaler or inability to use the device
  • Unable or unlikely to follow a meal plan that includes at least 2 meals/day (with or without a third meal or additional snacks)
  • A lack of compliance with medication or procedures that, in the PI's opinion, may affect the trial data or subject safety and that precludes the subject from further participation in the trial
  • Any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical trial or could limit the validity of the informed consent or impair the subject's ability to participate in the trial
  • An episode of severe hypoglycemia between Visit 1 and Visit 4
  • Any hospitalization or emergency visit due to poor diabetic control within 6 months of Visit 1
  • Any hospitalization or emergency visit due to poor diabetic control between Visit 1and Visit 4
  • Exposure to any investigational medications or devices within the previous 30 days before trial entry, except for those taken during participation in another clinical trial while participating in this trial
  • Unable or unlikely to comprehend and follow the trial protocol (including SMBG and diabetes education)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196104

  Show 29 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01196104     History of Changes
Other Study ID Numbers: MKC-TI-162
Study First Received: August 30, 2010
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Aspiration
Diabetes Mellitus
Diabetes Mellitus, Type 2
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014