Diabetes Mellitus: Type 1Phase 2NCT00662857

A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro

A Phase 2 study testing Technosphere® Insulin Inhalation Powder, Technosphere Insulin® Inhalation Powder and RAA Population in people with Diabetes Mellitus: Type 1, run by Mannkind Corporation at 2 sites 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

28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue). Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Diabetes Mellitus: Type 1
What is being tested?: Technosphere® Insulin Inhalation Powder, Technosphere Insulin® Inhalation Powder and RAA Population
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesUnited States
Study dates: Apr 2008to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Males and Females > 18 and < 60 years of age Clinical diagnosis of type 1 diabetes mellitus with stable anti-diabetic regimen for at least 90 days prior to Screening BMI of < 30 kg/m2 Non-smokers (never smoked or former smokers (> 6 months since cessation) Pulmonary Function Testing (FEV1 > 70%, FEV1/FVC > 70%, TLC > 80% DLco [unc] > 70% of Predicted Written Informed consent

Who cannot join

Two or more severe hypoglycemic episodes within 6 months of Screening/Visit 1 Severe complications of diabetes Previous exposure to any inhaled insulin product other than TI inhalation Powder or similar formulation Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria Respiratory tract infection within 8 weeks prior to Screening/Visit 1 History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease (eg. Obstructive sleep apnea), confirmed by pulmonary function testing, and/or radiologic findings Major organ system diseases including seizures, heart failure, uncontrolled hypertension, cancer within the past 5 years, liver disease, anemia or autoimmune disorder Clinically significant abnormalities on screening laboratory evaluation Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control Unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Profil Institute for Clinical Research Inc.
Chula Vista, California, 91911
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 2, Open-Label, Randomized, 2-Way Crossover, Clinical Trial to Compare the Pharmacokinetics of 2 Formulations of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder and to Determine the Bioavailability of a 30 Unit Cartridge of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder Versus a 10 Unit Subcutaneous Injection of Insulin Lispro in Subjects With Type 1 Diabetes Mellitus

Read the detailed description

28 eligible subjects were planned to be enrolled to determine bioequivalence and safety parameters of two 15 U TI Inhalation Powder cartridges versus one 30 U TI Inhalation Powder cartridge, according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30 U TI Inhalation Powder cartridge to a single subcutaneous injection of 10 IU of RAA will be compared.

Conditions: Diabetes Mellitus: Type 1
Being tested: Technosphere® Insulin Inhalation Powder, Technosphere Insulin® Inhalation Powder, RAA Population
Keywords: Diabetic adult male, diabetic adult female
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

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

Technosphere® Insulin Inhalation PowderDrug
TI Inhalation Powder, two 15 U cartridges
Technosphere Insulin® Inhalation PowderDrug
TI Inhalation Powder, one 30 U cartridge
RAA PopulationDrug
RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.

Study groups in NCT00662857
Study group	Role	What they receive
1: TI Inhalation Powder A	Experimental	Technosphere® Insulin Inhalation Powder, two 15 U cartridges Receives: Drug: Technosphere® Insulin Inhalation Powder
2: TI Inhalation Powder B	Experimental	Technosphere® Insulin Inhalation Powder, one 30 U cartridge Receives: Drug: Technosphere Insulin® Inhalation Powder
3: RAA Population	Experimental	Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro Receives: Drug: RAA Population

What is being measured

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

Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360
Dose-normalized baseline-corrected area under the serum insulin vs. time curve
Measured: 0 to 360 minutes post-dose
Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.
Maximum observed baseline-corrected serum insulin concentration
Measured: 0 to 360 minutes post-dose
Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax
Measured: 0 to 360 minutes post-dose
Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro
Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)
Measured: 0 to 360 minutes post-dose

Timeline

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

Apr 2008Dec 2008

First posted21 Apr 2008 (estimated)
Study startApr 2008
Primary completionNov 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus: Type 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00662857
Sponsor's protocol ID: MKC-TI-116
Status last verified: Oct 2014
First submitted: 16 Apr 2008
Last updated: 16 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-Label, Randomized, 2-Way Crossover, Clinical Trial to Compare the Pharmacokinetics of 2 Formulations of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder and to Determine the Bioavailability of a 30 Unit Cartridge of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder Versus a 10 Unit Subcutaneous Injection of Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00662857
Acronym / sponsor ID: MKC-TI-116
Conditions: Diabetes Mellitus: Type 1
Keywords: Diabetic adult male, diabetic adult female
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Mannkind CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Nov 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 21 Apr 2008 (estimated)
Results: Posted 16 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1: TI Inhalation Powder A	Experimental	Drug: Technosphere® Insulin Inhalation PowderTechnosphere® Insulin Inhalation Powder, two 15 U cartridges
2: TI Inhalation Powder B	Experimental	Drug: Technosphere Insulin® Inhalation PowderTechnosphere® Insulin Inhalation Powder, one 30 U cartridge
3: RAA Population	Experimental	Drug: RAA PopulationRapid Acting Analogue subjects received 10 IU sc Insulin Lispro

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Males and Females > 18 and < 60 years of age Clinical diagnosis of type 1 diabetes mellitus with stable anti-diabetic regimen for at least 90 days prior to Screening BMI of < 30 kg/m2 Non-smokers (never smoked or former smokers (> 6 months since cessation) Pulmonary Function Testing (FEV1 > 70%, FEV1/FVC > 70%, TLC > 80% DLco [unc] > 70% of Predicted Written Informed consent

Key exclusion criteria (1 listed)

Two or more severe hypoglycemic episodes within 6 months of Screening/Visit 1 Severe complications of diabetes Previous exposure to any inhaled insulin product other than TI inhalation Powder or similar formulation Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria Respiratory tract infection within 8 weeks prior to Screening/Visit 1 History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease (eg. Obstructive sleep apnea), confirmed by pulmonary function testing, and/or radiologic findings Major organ system diseases including seizures, heart failure, uncontrolled hypertension, cancer within the past 5 years, liver disease, anemia or autoimmune disorder Clinically significant abnormalities on screening laboratory evaluation Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control Unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Technosphere® Insulin Inhalation PowderTI Inhalation Powder, two 15 U cartridges	Drug	1: TI Inhalation Powder A
Technosphere Insulin® Inhalation PowderTI Inhalation Powder, one 30 U cartridge	Drug	2: TI Inhalation Powder B
RAA PopulationRAA Population: All subjects received a single 10 IU sc injection of insulin lispro.	Drug	3: RAA Population

Primary outcome

Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360
Time frame: 0 to 360 minutes post-dose
Dose-normalized baseline-corrected area under the serum insulin vs. time curve
Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.
Time frame: 0 to 360 minutes post-dose
Maximum observed baseline-corrected serum insulin concentration
Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax
Time frame: 0 to 360 minutes post-dose
Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro
Time frame: 0 to 360 minutes post-dose
Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)

Results and safety

Results posted to the registry on 16 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro	13	13
TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro	16	16

Primary outcome: Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360

Time frame: 0 to 360 minutes post-dose. Least squares mean (Standard Error). Unit: (micro U)*min/mL

Measure	Techosphere Insulin - A (2 x 15 U) n = 25	Techosphere Insulin - B (1 x 30 U) n = 25
Value	3337.2 (1.096)	3396.6 (1.096)

Techosphere Insulin - A (2 x 15 U) vs Techosphere Insulin - B (1 x 30 U): Ratio of Geometric Means: 0.982 (90% CI 0.846 to 1.141)

Population analysed: Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).

Primary outcome: Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.

Time frame: 0 to 360 minutes post-dose. Least squares mean (Standard Error). Unit: (micro U)/mL

Measure	Techosphere Insulin - A (2 x 15 U) n = 25	Techosphere Insulin - B (1 x 30 U) n = 25
Value	65.72 (1.098)	69.08 (1.098)

Techosphere Insulin - A (2 x 15 U) vs Techosphere Insulin - B (1 x 30 U): Ratio of Geometric Means: 0.951 (90% CI 0.823 to 1.099)

Primary outcome: Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax

Time frame: 0 to 360 minutes post-dose. Median (Full Range). Unit: min

Measure	Techosphere Insulin - A (2 x 15 U) n = 25	Techosphere Insulin - B (1 x 30 U) n = 25
Value	10 (5 to 24)	10 (5 to 20)

Techosphere Insulin - A (2 x 15 U) vs Techosphere Insulin - B (1 x 30 U): Median Difference (Final Values): 0, p = 0.3531, Signed Rank Test

Primary outcome: Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro

Time frame: 0 to 360 minutes post-dose. Least squares mean (Standard Error). Unit: (micro U)*min/mL

Measure	Techosphere Insulin - B (1 x 30 U) n = 25	10 U Subcutaneous (sc) Insulin Lispro n = 25
Value	3406.8 (1.095)	7404.0 (1.102)

Techosphere Insulin - B (1 x 30 U) vs 10 U Subcutaneous (sc) Insulin Lispro: Ratio of Geometric Means: 0.460 (90% CI 0.366 to 0.578)

Population analysed: Rapid-acting insulin Analogue (RAA) Population All subjects who had serum insulin concentration data for both TI Inhalation Powder B and insulin lispro and were deemed to be protocol compliant (no major protocol violations during the clinical trial).

Adverse events

Time frame: From time of first dose to 30d after last dose; Serious adverse event (SAE) = until resolution. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Techosphere Insulin - A (2 x 15 U)	0 of 27 (0%)	9 of 27 (33.3%)	Not reported
Techosphere Insulin - B (1 x 30 U)	0 of 29 (0%)	14 of 29 (48.3%)	Not reported
10 U Subcutaneous (sc) Insulin Lispro	0 of 26 (0%)	5 of 26 (19.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360 (time frame: 0 to 360 minutes post-dose). The study lists 4 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 NCT00662857.

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 16 Oct 2014.