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Trial record 27 of 47 for:    mannkind

Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01982604
First received: November 6, 2013
Last updated: October 1, 2014
Last verified: October 2014
  Purpose
A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.

Condition Intervention Phase
Healthy Volunteers
Drug: TI-Inhalation Powder A
Drug: TI-Inhalation Powder B
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Randomized, Crossover Clinical Trial to Evaluate PK/PD of 30 U TI Inhalation Powders Prepared With Insulin From Two Different Suppliers

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes [ Time Frame: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240 ]
  • Cmax (maximum serum insulin concentration) [ Time Frame: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240 ]

Secondary Outcome Measures:
  • GIR (area-under-the-serum Glucose Infusion Rate) [ Time Frame: 0 to 360 ]

Enrollment: 38
Study Start Date: November 2013
Study Completion Date: August 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence (Group) 1

Subjects randomized to Sequence 1 will receive TI in the following sequence:

TI-Inhalation Powder A TI-Inhalation Powder B

*30 units (10 units + 20 units)

Drug: TI-Inhalation Powder A
Inhaled Insulin
Drug: TI-Inhalation Powder B
Inhaled Insulin
Experimental: Sequence (Group) 2

Subjects randomized to Sequence 2 will receive TI in the following sequence:

TI-Inhalation Powder B TI-Inhalation Powder A

*30 units (10 units + 20 units)

Drug: TI-Inhalation Powder A
Inhaled Insulin
Drug: TI-Inhalation Powder B
Inhaled Insulin

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis

    • HNVs with a screening blood pressure less than 140/90 mm Hg
    • Subjects who have hypertension controlled with up to 1 medication and who have a blood pressure less than 140/90 mm Hg
    • Note: For subjects with blood pressure at or above 140/90 mm Hg; two additional readings 5 minutes apart are allowed but the last blood pressure reading must be in range
    • Subjects who have hypercholesterolemia controlled with up to 1 medication and who have a low-density lipoprotein value less than 160 mg/dL
  • Good venous access for blood draws
  • No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing < 100 ng/mL
  • Body mass index (BMI) < 32 kg/m2
  • Completion of informed consent form

Exclusion Criteria:

  • Blood donation (500 mL) within the last 8 weeks
  • Fasting blood sugar >100 mg/dL
  • History of coronary artery disease, peripheral vascular disease, or congestive heart failure
  • Allergy to study drug, components of Boost and Boost Plus, or other study material
  • Clinically significant active or chronic illness
  • History of asthma, COPD, or any other clinically relevant chronic lung disease
  • Respiratory tract infection within 4 weeks before screening
  • History of drug or alcohol abuse within the past 5 years
  • Positive urine drug screen
  • Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
  • Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism
  • History of malignancy within the 5 years before screening (other than basal cell carcinoma)
  • History of human immunodeficiency virus (HIV) infection or hepatitis B or C
  • Women who are pregnant, lactating, or planning to become pregnant during the clinical study period
  • Women of childbearing potential (premenopausal who have not undergone hysterectomy or bilateral tubal ligation, or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile.
  • Any subject who, in the opinion of the PI or a designee, appears not to be qualified for this study
  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: NCT01982604

Locations
United States, California
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Mannkind Corporation
  More Information

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01982604     History of Changes
Other Study ID Numbers: MKC-TI-179
Study First Received: November 6, 2013
Last Updated: October 1, 2014

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 22, 2017