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Type 1 Diabetes MellitusPhase 1NCT01544881

Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes

A Phase 1 study testing Technosphere Insulin Inhalation Powder and Rapid Acting Analog in people with Type 1 Diabetes Mellitus, run by Mannkind Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Technosphere Insulin Inhalation Powder and Rapid Acting Analog
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Mar 2012to Jan 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Men and women aged 18 to 60 years
  • One of more daily sc insulin injections of any insulin type or insulin pump use
  • Body mass index (BMI) = 30 kg/m2
  • Pulmonary function tests (PFTs) conducted at Visit 1:
  • FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
  • FVC ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
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  • Diagnosis of type 1 diabetes for at least 12 months
  • Good venous access for blood draws
  • Written informed consent provided
  • No smoking in the previous 6 months (including cigarette, cigars, pipes) and negative urine cotinine testing (<100 ng/mL)
  • C-peptide < 0.3 ng/mL
  • Hemoglobin A1c (HbA1c) = 10.0%

Who cannot join

  • Total daily insulin requirement of = 1.4 U/kg body weight
  • Serum creatinine = 2.0 mg/dL in men and > 1.8 mg/dL in women
  • Blood donation of 500 mL within the previous 56 days
  • Current treatment with pramlintide acetate or exenatide
  • Unstable diabetes control and evidence of severe complications of diabetes (ie, autonomic neuropathy)
  • History of chronic obstructive pulmonary disease (COPD) or asthma, or any other clinically important pulmonary disease confirmed by pulmonary function testing or radiologic findings
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  • Upper respiratory tract infection within 8 weeks before screening
  • History of coronary artery disease, peripheral vascular disease, or congestive heart failure
  • Allergy to study drug, food, or other study material (eg, peanuts, soy products)
  • Clinically significant active or chronic illness
  • History of drug or alcohol abuse
  • 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 (except metformin)
  • 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 (defined as premenopausal and not surgically sterilized 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
  • Inability, in the opinion of the PI or a designee, to adequately inhale TI Inhalation Powder
  • Any subject who, in the opinion of the PI or a designee, appears to not be qualified for this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Profil Institute for Clinical Research

    Chula Vista, California, 91911

Other trials in United States

About this study

Official title: A Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Study in Subjects With Type 1 Diabetes Comparing Insulin Exposure & Response Following Inhalation of Technosphere Insulin Inhalation Powder Using the Gen2C Inhaler Vs Subcutaneous Rapid-Acting Analog

This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.

Read the detailed description

Subjects with Type 1 diabetes will be randomized to either one dose of TI inhaled using the Gen2C device, or one dose of subcutaneously injected Rapid Acting Analog (RAA) and crossed over.

Crossover Sequences:

Sequence #1: Period 1 - one 20 U cartridge of TI; Period 2 - 8 U of RAA

Sequence #2: Period 1 - 8 U RAA; Period 2 - one 20 U cartridge of TI

An euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to characterize the pharmacokinetics (PK) of the one dose of TI Inhalation Powder using the Gen2C inhaler as compared to one dose of subcutaneous RAA.

Being tested
Technosphere Insulin Inhalation Powder, Rapid Acting Analog
Keywords
Pharmacokinetics, Pharmacodynamics, Hyperglycemia, Insulin
Medical subject headings
Diabetes Mellitus, Type 1, Hyperglycemia, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technosphere Insulin Inhalation PowderDrug

    Also called TI

    Inhalation Powder using the Gen2C inhaler

  • Rapid Acting AnalogDrug

    Also called RAA

    Subcutaneous Injection

Study groups in NCT01544881
Study groupRoleWhat they receive
TI Inhalation PowderExperimentalTechnosphere Insulin Inhalation Powder using the Gen2C inhaler
Receives: Drug: Technosphere Insulin Inhalation Powder
RAAActive comparatorRapid Acting Analog
Receives: Drug: Rapid Acting Analog

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PK measures for TI Inhalation Powder (20U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing

    Measured: Crossover 1 time within 3 - 10 days

  2. PK measures for RAA (8U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing

    Measured: Crossover 1 time within 3 - 10 days

Secondary outcomes (3)

  1. Safety variables including adverse events (AEs), clinical laboratory tests, vital signs and physical examinations

    Measured: Crossover 1 time within 3 - 10 days

  2. Area under serum glucose infusion rate (GIR AUC 0-360) for TI Inhalation Powder (20U) as measured by: GIR AUC 0-360 timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing

    Measured: Crossover 1 time within 3 - 10 days

  3. Area under serum glucose infusion rate (GIR AUC 0-360) for RAA (8U) as measured by: GIR AUC 0-360 timepoints: 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing

    Measured: Crossover 1 time within 3 - 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionSep 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544881
Sponsor's protocol ID
MKC-TI-177
Status last verified
Jan 2013
First submitted
23 Feb 2012
Last updated
25 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Technosphere Insulin Inhalation Powder and Rapid Acting Analog in people with Type 1 Diabetes Mellitus, run by Mannkind Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK measures for TI Inhalation Powder (20U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing (time frame: Crossover 1 time within 3 - 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01544881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013.

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