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

NCT00934414 | Completed Phase 2

• 1 other identifier: MKC-TI-016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• To compare the relative bioavailability and bioeffect of TI Inhalation Powder in subjects with type 2 diabetes who smoke and who do not smoke to determine relative insulin bioavailability

  15 to 52 days

Study Arms (2)

Smokers

EXPERIMENTAL

Drug: Technosphere Insulin Inhalation Powder

Non-Smokers

EXPERIMENTAL

Drug: Technosphere Insulin Inhalation Powder

Interventions

Technosphere Insulin Inhalation Powder DRUG

30U

Non-Smokers; Smokers

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Non Smoking: FVC of = 80% NHANES III predicted value.
• Non Smoking: DLco of = 70% (uncorrected) Miller predicted value.
• Non Smoking: No upper respiratory infections within the last 15 days or lower respiratory infection within the last 30 days.
• Non Smoking: Must be of non-childbearing potential or using adequate birth control measures
• Smoking: Positive cotinine test.

You may not qualify if:

• 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).
• Myocardial infarction or stroke within the preceding six (6) months.
• Positive hepatitis B (HBsAg) or positive Human Immunodeficiency Virus (HIV) serology or active Hepatitis C (HepCAb) at screening.
• History or presence of clinically significant cardiovascular, hepatic, gastrointestinal, neurological or infectious disorders capable of altering the absorption, metabolism or elimination of drugs, or constituting a significant risk factor when taking trial medication.
• ALT or AST \> 3 times the upper limit of the normal reference range.
• Anemia (hemoglobin levels \< 11 g/dL for females and \< 12 g/dL for males).

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: August 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: September 1, 2006
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

US (1)