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Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 Diabetes | Clinical Trials | Clareo Health

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Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 Diabetes

A Parallel, Controlled, Multi-Center, Single-Dose, One-Period Euglycemic Clamp Study Comparing Prandial Inhalation of Technosphere Insulin in Smokers and Non-Smokers With Type 2 Diabetes

NCT00934414•Mannkind Corporation

View on ClinicalTrials.gov

Summary

Twelve smoking and twelve non-smoking subjects with Type 2 Diabetes Mellitus will be enrolled in this study to determine the effect of Technosphere® Insulin Inhalation Powder on insulin in the body during a clamp procedure.

Detailed Description

MKC-TI-016 is a parallel, prospective, controlled, open-label, 1-period, single-dose trial utilizing a hyperinsulinemic-euglycemic clamp procedure to evaluate the bioavailability and bioeffect of inhaled TI Inhalation Powder in type 2 diabetic subjects who smoke compared to nonsmoking type 2 diabetic subjects.

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Non Smoking: Clinical diagnosis of type 2 diabetes mellitus.
•Non Smoking: Current basal and prandial insulin therapy for at least 6 weeks either alone or in combination with = 2 OHA
•Non Smoking: Negative urine cotinine test.
•Non Smoking: Non-smoker for at least 2 years.
•Smoking: Clinical diagnosis of type 2 diabetes mellitus.
•Smoking: Have been smoking for at least 5 years
•Non Smoking: Body Mass Index (BMI) of = 40 kg/m2.
•Non Smoking: Glycosylated hemoglobin (HbA1c) of = 12%.
•Non Smoking: If other medications (other than oral anti-diabetic agents) in addition to insulin are taken at screening, the subject must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least 12 weeks immediately prior to trial enrollment.
•Non Smoking: Forced expiratory volume in one second / forced vital capacity (FEV1/FVC) of = NHANES III predicted Lower Limit of Normal.
+14 more criteria

Exclusion Criteria

•Diabetes mellitus type 1.
•Total daily insulin requirement of = 1.4 U/kg.
•Intake of any drug or herbal preparation which, in the evaluation of the Investigator, may interfere with the clinical trial results by causing clinically relevant interference with glucose utilization, insulin action, or recovery from hypoglycemia (eg, systemic corticosteroids, oral or inhaled glucocorticosteroids).
•History of hypersensitivity to the trial drug or to drugs with similar chemical structures.
•Treatment with any investigational drug within 90 days prior to enrollment of trial.
•Progressive fatal disease.
•History of malignancy within five years of trial entry (other than basal cell carcinoma).
•Evidence of severe secondary complications of diabetes (neuropathy, nephropathy as evidenced by creatinine \> 1.6 mg/dL for females or \> 1.8 mg/dL for males, Stage III or IV retinopathy (according to the MKC diabetic retinopathy scale, see Appendix 1.1 of protocol), or severe peripheral vascular disease).
•Previous history of anaphylaxis or angioedema.
•Evidence of clinically significant autonomic neuropathy (gastroparesis, orthostatic hypotension or hypoglycemia unawareness).
+11 more criteria

Locations (1)

Profil Institute for Clinical Research

Chula Vista, California, United States

Key Dates

Start Date

August 1, 2004

Primary Completion Date

August 1, 2006

Completion Date

September 1, 2006

Last Updated

July 8, 2009

Enrollment

ACTUAL participants

Conditions

Diabetes Type 2

Interventions

Technosphere Insulin Inhalation Powder

DRUG

Disentangling the Effect of Brain Insulin Resistance on Brain Health

NCT07374705

Diabetes Type 2Diabetes Type 1

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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: July 8, 2009Data 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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Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

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