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Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

NCT00309244•Mannkind Corporation

View on ClinicalTrials.gov

Summary

The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women ≥ 18 and ≤ 80 years old
•Clinical diagnosis of type 2 diabetes mellitus
•HbA1c \> 7.0% and ≤ 11.0%
•BMI ≤ 40 kg/m2
•Negative smoking status and urine cotinine test
•Written informed consent
•Receiving sc insulin 2-3 times daily administered as any of the following 3 regimens: self-mix regimen, pre-mix regimen, or long-acting analogue and regular or rapid-acting insulin analogue not to exceed 3 daily injections. Subjects may also have received oral antidiabetic agents including metformin or thiazolidinediones.
•No dose adjustments for insulin and oral antidiabetic agents within the preceding 6 weeks.
•FEV1 ≥ 70% of NHANES III predicted; TLC) ≥ 80% of predicted (Intermountain Thoracic Society); DLCO uncorrected ≥ 70% of predicted

Exclusion Criteria

•Total daily dose of insulin ≥1.4 IU/kg body weight
•Treatment with any sulfonylureas and/or meglitinides and/or alpha-glucosidase inhibitors within the preceding 8 weeks
•Treatment with pramlintide acetate (Symlin®), and/or any incretins (e.g., exenatide \[Byetta®\]) within the preceding 8 weeks
•Unstable diabetes mellitus control, defined as 2 or more episodes of severe hypoglycemia (requiring third party intervention) and/or any hospitalization or emergency room visit due to poor diabetic control or hyperglycemia requiring hospitalization within the preceding 6 months
•Exposure to an inhaled insulin at any time, treatment with an investigational drug within the preceding 3 months, and/or current participation in another clinical trial
•Allergy to insulin or to any drugs to be used as part of the clinical trial, or history of hypersensitivity to the investigational drug or to drugs of similar chemical structures
•History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes as evidenced by serum aspartate aminotransferase (AST)and/or alanine aminotransferase (ALT) ≥ 3 x Upper Limit of Normal (ULN)(Includes active hepatitis A, positive hepatitis B and/or hepatitis C serology)
•Serum creatinine \> 1.8 mg/dL in women and \> 2.0 mg/dL in men History of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease confirmed by documented history, pulmonary function testing, or radiologic findings
•Congestive heart disease graded as class III or class IV according to New York Heart Association criteria and subjects currently being treated pharmacologically for ventricular dysrhythmias using amiodarone
•History of myocardial infarction, cardiac surgery, coronary angioplasty, and/or stroke within the preceding 3 months
+13 more criteria

Locations (151)

Coastal Clinical Research Inc

Mobile, Alabama, United States

Quality of Life Medical & Research Center

Tucson, Arizona, United States

Southern Arizona VA Healthcare System

Tucson, Arizona, United States

Tucson Clinical Research

Tucson, Arizona, United States

International Clinical Research Network

Chula Vista, California, United States

Saad Hijazi MD Inc

Fresno, California, United States

Valley Research

Fresno, California, United States

Diabetes/Lipid Management and Research Center

Huntington Beach, California, United States

South Bay Clinical Research

Inglewood, California, United States

Southern California Endocrine Center

Pasadena, California, United States

Key Dates

Start Date

February 1, 2006

Primary Completion Date

August 1, 2008

Completion Date

September 1, 2008

Last Updated

October 16, 2014

Enrollment

677

ACTUAL participants

Conditions

Diabetes Type 2

Interventions

Technosphere® Insulin Inhalation Powder

DRUG

70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

DRUG

Disentangling the Effect of Brain Insulin Resistance on Brain Health

NCT07374705

Diabetes Type 2Diabetes Type 1

View study

RECRUITINGNA

Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

NCT05912647

DiabetesDiabetes Type 2

View study

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.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

Inclusion Criteria

Exclusion Criteria

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Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

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