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TERMINATEDPHASE3

Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

A Phase3, Multi-Center, Open-Label, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With Lantus® Versus Humalog® in Combination With Lantus® in Subjects With Type 1 Diabetes Mellitus Over a 16-Week Treatment Period

NCT00700622•Mannkind Corporation

View on ClinicalTrials.gov

Summary

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women ≥ 18 and ≤ 80 years old
•Clinical diagnosis of type 1 diabetes mellitus for more than 12 months
•Body mass index (BMI) ≤ 30 kg/m2
•Stable antidiabetic regimen of sc insulin therapy at a total daily dose ≤ 1.5 IU/kg/day
•HbA1c \> 7.0% and ≤ 9.0%
•C-peptide level ≤ 0.30 pmol/mL
•Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for at least the preceding 6 months
•Negative urine cotinine defined as ≤ 100 ng/mL
•Pulmonary function tests (PFTs):
•* Forced expiratory volume in 1 second (FEV1) ≥ 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
+5 more criteria

Exclusion Criteria

•Treatment with any type of antidiabetic drugs, other than sc insulin, within the preceding 12 weeks
•Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Visit 1 and Visit 5
•Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Visit 1, or hospitalization or emergency room visit due to poor diabetic control between Visit 1 and Visit 5
•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; history of foot ulcers; nontraumatic amputations due to gangrene; or vascular claudication
•Previous exposure to an inhaled insulin product within 3 months of Visit 1
•History of insulin pump use within 6 weeks of Visit 1
•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
•Significant improvement in pre- to postbronchodilator spirometry at Visit 1 (defined as an increase of 12% and 200 mL in either FEV1 or FVC)
•History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, obstructive sleep apnea) confirmed by pulmonary function testing or radiologic findings
•Inability to perform spirometry maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria
+32 more criteria

Locations (22)

Diabetes/Lipid Management and Research Center

Huntington Beach, California, United States

The Whittier Institute for Diabetes Clinical Trials

La Jolla, California, United States

Dorothy L & James E Frank Diabetes Research Institute

San Mateo, California, United States

Barbara Davis Center for Diabetes Young Adult Clinic

Aurora, Colorado, United States

University of Miami Diabetes Research Institute

Miami, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Washington University School of Medicine

St Louis, Missouri, United States

Deaconess Billings Clinic Research Center

Billings, Montana, United States

Key Dates

Start Date

May 1, 2008

Primary Completion Date

November 1, 2009

Completion Date

March 1, 2010

Last Updated

October 16, 2014

Enrollment

130

ACTUAL participants

Conditions

Diabetes, Type 1

Interventions

Technosphere Insulin

DRUG

Insulin glargine

DRUG

Insulin lispro

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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