NCT01982604

CompletedPhase 1

Comparison of 30 Units of TI (Technosphere® Insulin) Prepare...

Mannkind Corporation Source

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Other study identifiers

Sponsor study identifier

MKC-TI-179

Study Type

interventional

Actual enrollment (reported)

38

Locations

1 country

Sites

1

Timeline

Study Start

November 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2014

Actual (reported)

Study Completion

August 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 38 participants
Study completion date: August 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 6, 2013
Actual (reported)
First Posted
November 13, 2013
Actual (reported)
Primary Completion
February 2014
Actual (reported)
Study Completion
August 2014
Actual (reported)

Last Updated: October 2, 2014
Status Verified: October 2014
Last Update Submitted: October 1, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (1)

GIR (area-under-the-serum Glucose Infusion Rate)
0 to 360

Study Arms (2)

Sequence (Group) 1

EXPERIMENTAL

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 ADrug: TI-Inhalation Powder B

Sequence (Group) 2

EXPERIMENTAL

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 ADrug: TI-Inhalation Powder B

Interventions

TI-Inhalation Powder ADrug

Inhaled Insulin

Sequence (Group) 1Sequence (Group) 2

TI-Inhalation Powder BDrug

Inhaled Insulin

Sequence (Group) 1Sequence (Group) 2

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

Sponsors & Collaborators

Mannkind Corporation
Industrylead

Study Sites (1)

Chula Vista, California, 91911, United States

Enrollment

38 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

November 2013

Date type not reported

This date has not been verified as actual or estimated.

Phase 1

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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

You may not qualify if:

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.
+1 more criteria

Contact the study team to confirm eligibility.

Primary Completion

February 2014

Actual (reported)

Study Completion

August 2014

Actual (reported)

Last Updated

October 2, 2014

Record last verified: 2014-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01982604
Data provider: ClinicalTrials.gov
Source updated: 2014-10-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:37 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Sequence (Group) 1

Sequence (Group) 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations