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

Sponsor
Mannkind Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01982604
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
9
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: TI-Inhalation Powder A
  • Drug: TI-Inhalation Powder B
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes [5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240]

  2. Cmax (maximum serum insulin concentration) [5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240]

Secondary Outcome Measures

  1. GIR (area-under-the-serum Glucose Infusion Rate) [0 to 360]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Chula Vista California United States 91911

Sponsors and Collaborators

  • Mannkind Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01982604
Other Study ID Numbers:
  • MKC-TI-179
First Posted:
Nov 13, 2013
Last Update Posted:
Oct 2, 2014
Last Verified:
Oct 1, 2014

Study Results

No Results Posted as of Oct 2, 2014