Diabetes Mellitus, Type 1Phase 3NCT00332826
Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
A Phase 3 study testing Technosphere Insulin in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Mannkind Corporation at 78 sites in 11 countries.
Trial summary
The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
- What is being tested?
- Technosphere Insulin
- How many people
- 3 participants
- Where
- 78 sitesin 11 countries
- Study dates
- Jun 2006to Oct 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
- Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
- Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
- Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period.
- Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
- Body mass index (BMI) < 40kg/m2
- HbA1c >6.0% to <11.5%
Who cannot join
- Severe complications of diabetes in the opinion of the investigator
- Seizure disorder
- Significant cardiovascular dysfunction and/or history within 3 months of screening
- Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy.
- Clinical nephrotic syndrome or renal dysfunction or disease
- Total daily insulin requirement of >1.4 U/kg body weight
Show all 24Show fewer
- Clinical diagnosis of Step 4 asthma
- Use of >6 puffs/day of fast acting bronchodilator
- Currently using an insulin delivery pump
- Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
- Two or more severe hypoglycemic episodes within the past 6 months.
- Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
- Current use of systemic steroids
- Subjects who currently smoke tobacco or who have smoked within the past 6 months
- Urine cotinine test of > 100ng/ml
- Current drug or alcohol abuse
- Clinically significant abnormalities on screening laboratory evaluation
- Cancer within the past 5 years or any history of lung neoplasms
- History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
- Active infection or history of severe infection with 30 days of screening.
- Anemia
- History of anaphylaxis and/or angioneurotic edema
- Diagnosis of chronic obstructive pulmonary disease (COPE)
- Previous exposure to any inhaled insulin product
Trial locations and contacts
78 sites in 11 countries.
78 sites in 11 countries
United States25 sites
Pinaccle Trials Inc (SMO)
Atlanta, Georgia, 30329
Executive Health and Research Associates Inc
Atlanta, Georgia, 30342
Franklin Square Hospital
Baltimore, Maryland, 21237
Billings Clinic Research Division
Billings, Montana, 59101
Associated Pharmaceutical Research Center Inc
Buena Park, California, 90620
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Cleveland Clinic Dept of Endocrinology
Cleveland, Ohio, 44195
Carolinas Research
Concord, North Carolina, 28025
Atlanta Pharmaceutical Research Center
Dunwoody, Georgia, 30338
Healthcare Research
Florissant, Missouri, 63031
Family Medical Center
Foothill Ranch, California, 92610
Your Doctors Care
Hillsborough, New Jersey, 08844
Health Care Partners Medical Group
Long Beach, California, 90806
Golden Pine Clinical Research
Long Beach, California, 90807
Keck USC School of Medicine
Los Angeles, California, 90033
Eastside Comprehensive Medical Center
New York, New York, 10021
Arizona Research Center
Phoenix, Arizona, 85023
Northwest Medical Center
Phoenix, Arizona, 85029
Southeastern Endocrine & Diabetes
Roswell, Georgia, 30076
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229
MedEx Healthcare Research Inc(009)
St Louis, Missouri, 63117
Premiere Pharmaceutical Research LLC
Tempe, Arizona, 85282
Hopewell Valley Family Medicine PA
Trenton, New Jersey, 08618
Canyon Internal Medicine
Tucson, Arizona, 85712
McLennan County Medical Education and Research Foundation
Waco, Texas, 76707
Russia13 sites
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, 650061
NI Principal Military Clinical Hospital n a academician N.N. Burdenko
Moscow, RUS, 105229
Moscow State Medico-Stomatological University City Hospital # 23
Moscow, RUS, 109240
Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
Moscow, 105077
City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University
Moscow, 117 198
Central Clinical Hospital of Russian Science Academy
Moscow, 117 593
City Clinical Hospital # 61
Moscow, 119 048
Russian Scientific Center of Restoration Medicine & Balneology
Moscow, 121069
Central Medical Sanitary Unit #122
Saint Petersburg, RUS, 194291
City Hospital # 2 Endocrinology Department
Saint Petersburg, RUS, 194354
St Petersburg Medical Academy (Ilkovich)
Saint Petersburg
Smolensk Medical Academy Smolensk Regional Clinical Hospital
Smolensk, RUS, 214018
Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, 150003
Brazil7 sites
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-070
Hospital Sao Lucas - PUCRS (Fritscher)
Porto Alegre, 90610-000
Hospital Nossa Senhora da Conceicao
Porto Alegre, 91350-200
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
Rio de Janeiro, 22271-100
CPClin-Centro de Pesquisas Clinicas
São Paulo, 01244-030
Clinica de Endocrinologia
São Paulo, 01323-001
Canada6 sites
Finchlea Medical Group
Brampton, Ontario, L6T 3J1
Courtice Health Centre
Courtice, Ontario, L1E 3C3
Parkwood Hospital
London, Ontario, N6C 5J1
The London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, N7T 4X3
Albany Medical Center
Toronto, Ontario, M4K 1N5
Windsor Professional Research
Windsor, Ontario, N8X 3V6
Poland6 sites
Klinika Endocrinologii Diabetologii I
Bialystock, POL, 15-276
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, POL, 15-435
Dzial Badan Klinicznych Malopoiskie
Krakow, POL, 30 510
III Oddzial Chorob Wewnetrznych Szpital
Krakow, POL, 31121
Oddzial Chorob Wewnetrznych Wojewodzki
Lodz, Zgierz, 95-100
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
Lodz, 90-153
Czechia5 sites
Surgery of Diabetology
Mělník, CZE, 276 01
InternÃ- a diabetologická Outpatient
Ostrava, Ostrava, 70900
I InternÃ- klinika
Ostrava, Ostrava, 728 80
Interni oddeleni nemocnice Na Homolce
Prague, CZE, 15031
Diabetologicka Outpatient Surgery of Diabetology
Slaný, CZE, 274 01
Ukraine5 sites
Donetsk State Medical University
Donetsk, UKR, 83003
Donetsk State Medical University
Donetsk, UKR, 83009
Railway Clinical Hospital on Donetsk Station
Donetsk, UKR, 83114
Chair Family Med of National Med University
Kiev, UKR, 04050
Institute of Endocrinology and Metabolism
Kiev, UKR, 04114
Mexico4 sites
Nuevo Sanatorio Durango
Delegacion Cuauhtemoc, 6700
Hospital Angeles de las Lomas
Huixquilucan, 52760
Hospital Angeles Mocel
Mexico City, Mexico City, 06726
Mexican Institute of Clinical Research
Mexico City, MX, 06700
United Kingdom4 sites
Addenbrooke's Hospital Department of Medicine
Cambridge, CB2 2QQ
Clinical Research Centre The Royal London Hospital
London, GBR, E1 2AT
Northern General Hospital
Sheffield, GBR, S5 7AU
Birmingham Heartland Hospital
West Midlands, GBR, B9 5SS
Argentina2 sites
DIM (Clinica Privada)
Buenos Aires, 1704
Ins De Inv Cardiovascular La Plata
La Plata
About this study
Official title: A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
- Being tested
- Technosphere Insulin
- Keywords
- Inhaled insulin, Diabetes Type I and II with Asthma
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere InsulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Non-safety related business decision to combine special population protocols
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332826
- Sponsor's protocol ID
- MKC-TI-105
- Status last verified
- May 2012
- First submitted
- 1 Jun 2006
- Last updated
- 4 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
- ClinicalTrials.gov ID
- NCT00332826
- Acronym / sponsor ID
- MKC-TI-105
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
- Keywords
- Inhaled insulin, Diabetes Type I and II with Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Non-safety related business decision to combine special population protocols
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 2 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
- Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
- Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
- Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period.
- Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
Key exclusion criteria (24 listed)
- Severe complications of diabetes in the opinion of the investigator
- Seizure disorder
- Significant cardiovascular dysfunction and/or history within 3 months of screening
- Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy.
- Clinical nephrotic syndrome or renal dysfunction or disease
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 | Drug | – |
Primary outcome
The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
Results and safety
The study was stopped early (reason given: Non-safety related business decision to combine special population protocols). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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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.
78 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Technosphere Insulin in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Mannkind Corporation at 78 sites in 11 countries.
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 7 inclusion and 24 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: stopped early, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Russia, Brazil, Canada, Poland and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Non-safety related business decision to combine special population protocols). Results are not available in the source record.
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?
The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2012; AzTrials last refreshed its copy on 8 Nov 2026.