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

NCT01196104 | Terminated Phase 3 Results

• 1 other identifier: MKC-TI-162
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 29

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (%) From Baseline to Week 16

  Change from Baseline in glycated hemoglobin at Week 16

  Baseline to Week 16

Secondary Outcomes (25)

• 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

• 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

Study Arms (2)

Technosphere® Insulin Inhalation Powder (TI)

EXPERIMENTAL

Insulin Glargine and Technosphere® Insulin Inhalation Powder

Drug: Technosphere® Insulin Inhalation Powder; Drug: Insulin Glargine

Comparator

ACTIVE COMPARATOR

Insulin Glargine and Insulin Aspart

Drug: Insulin Aspart; Drug: Insulin Glargine

Interventions

Technosphere® Insulin Inhalation Powder DRUG

Technosphere® Insulin Inhalation Powder (TI)

Insulin Aspart DRUG

Usual Care

Comparator

Insulin Glargine DRUG

Comparator; Technosphere® Insulin Inhalation Powder (TI)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Current or prior treatment with prandial or PreMix (70/30) insulin
• History of insulin pump use within 6 weeks of Visit 1
• Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
• History of chronic obstructive pulmonary disease (COPD), 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 (eg, symptomatic autonomic neuropathy)
• Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure \[New York Heart Association {NYHA} Class III or IV\])
• Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident
• History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (29)

Coastal Clinical Research Inc

Mobile, Alabama, 36608, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Health Care Partners Medical Group

Long Beach, California, 90806, United States

Location

Diabetes Research Center

Tustin, California, 92780, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Laureate Clinical Research Group

Atlanta, Georgia, 30308, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

Alta Pharmaceutical Research Center

Dunwoody, Georgia, 30338, United States

Location

John H Stoger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

LaPorte County Institute for Clinical Research Inc.

Michigan City, Indiana, 46360, United States

Location

Radiant Research Inc (Minneapolis)

Edina, Minnesota, 55435, United States

Location

Amin Radparvar's Private Practice

City of Saint Peters, Missouri, 63376, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Billings Clinic Research Center

Billings, Montana, 59101, United States

Location

Creighton Diabetes Center

Omaha, Nebraska, 68131, United States

Location

University of New Mexico HCS

Albuquerque, New Mexico, 87131, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, 11042, United States

Location

Endocrine Research Physicians East PA

Greenville, North Carolina, 27834, United States

Location

Your Diabetes Endocrine Nutrition Group, Inc.

Mentor, Ohio, 44060, United States

Location

Legacy Clinical Research

Portland, Oregon, 97232, United States

Location

OHSU Diabetes Center Research Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

The Endocrine Clinic

Memphis, Tennessee, 38119, United States

Location

Dallas Diabetes & Endocrine Center

Dallas, Texas, 75230, United States

Location

Baylor Endocrine Center

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

SAM Clinical Research Center

San Antonio, Texas, 78229, United States

Location

Exodus Healthcare Network

Magna, Utah, 84044, United States

Location

Diabetes Research Center -Fletcher Allen Health Care

South Burlington, Vermont, 05403, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Aspart; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Limitations and Caveats

\- Early termination of trial leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MannKind Corporation

aboss@mannkindcorp.com

201-983-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 8, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2012
• Last Updated: October 30, 2014
• Results First Posted: October 21, 2014

Record last verified: 2014-10

Locations

US (29)