Trial record 29 of 46 for:    mannkind

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

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00934414
First received: July 6, 2009
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Type 2
Drug: Technosphere Insulin Inhalation Powder
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • 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 [ Time Frame: 15 to 52 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2004
Study Completion Date: September 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smokers Drug: Technosphere Insulin Inhalation Powder
30U
Experimental: Non-Smokers Drug: Technosphere Insulin Inhalation Powder
30U

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.
  • Smoking: Current basal and prandial insulin therapy for at least 6 weeks either alone or in combination with = oral antihyperglycemic agents.
  • Smoking: BMI of = 40 kg/m2.
  • Smoking: HbA1c of 12%.
  • 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.
  • Smoking: FEV1/FVC = NHANES III Predicted Lower Limit of Normal
  • Smoking: FEV1 and FVC of = 60% NHANES III predicted value.
  • Smoking: DLco = 70% of (uncorrected) of Miller predicted value.
  • Smoking: No upper respiratory infections within the last 15 days or lower respiratory infection within the last 30 days.
  • Smoking: Must be of non-childbearing potential or using adequate birth control measures.

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).
  • 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).
  • On-going respiratory infection.
  • Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
  • Pregnancy, lactation, or the intent of becoming pregnant during the trial period.
  • Women of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, or surgical sterilization).
  • Current drug or alcohol abuse (regular alcohol intake > 14 units/week), or history which in the opinion of the investigator would not make the subject a suitable candidate for participation in this trial. A unit of alcohol is defined as 8 g of ethanol, ¼ liter of beer or 1 glass of wine or 1 measure of spirits.
  • Investigator or site personnel directly affiliated with this trial, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934414

Locations
United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Anders Boss, MannKind Corporation
ClinicalTrials.gov Identifier: NCT00934414     History of Changes
Other Study ID Numbers: MKC-TI-016
Study First Received: July 6, 2009
Last Updated: July 7, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014