Diabetes Type 2Phase 3NCT00539890
Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing Technosphere Insulin in people with Diabetes Type 2, run by Mannkind Corporation at 33 sites in Russia.
Trial summary
To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c >7.0% and <11.5%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Technosphere Insulin
- How many people
- 0 participants
- Where
- 33 sitesRussia
- Study dates
- Nov 2005to Jul 2006
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 2 years since diagnosis of type 2 diabetes mellitus
- Received subcutaneous (sc) insulin for at least 3 months
- Body Mass Index <44 kg/m2
- HbA1c>7.0% and <11.5%
- Serum creatinine <2.0 mg/dL for males and <1.8 mg/dL for females
- Baseline FVC and FEV1>70% and < 125% of predicted normal
Who cannot join
- Significant hepatic disease (AST/ALT3 x ULN)
- Diagnosis of Type 1 diabetes
- Severe complications of diabetes
- History of moderate to severe ketoacidosis within the past 3 months
- Upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days
- Diagnosis of HIV
Show all 18Show fewer
- Positive serology for hepatitis B or C
- COPD, emphysema, or asthma
- Current smokers or smoking history within the past 6 months
- Major psychiatric disorder precluding satisfactory completion of protocol
- Clinically significant heart disease disease, stroke or heart attack within the past 6 months
- Treatment with an investigational drug within 30 days
- Previous treatment with Technosphere/Insulin
- History of malignancy in the past 5 years except basal cell carcinoma
- Anemia (hemoglobin <10.5 g/dL for females and <11.5 g/dL (for males)
- Women who were pregnant of lactating
- History of hypersensitivity to drugs resembling FDKP carrier products
- Treatment with another inhaled insulin product during the duration of the study
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Russia33 sites
Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3
Chelyabinsk, RUS, 454021
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, 650061
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
Moscow, RUS, 105229
Moscow State Medico-Stomatological University City Hospital # 23
Moscow, RUS, 109240
Russian State Medical University
Moscow, RUS, 109263
Clinical Research Institute of Physic-Chemical Medicine Hospital # 29
Moscow, RUS, 111020
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
Moscow, RUS, 111399
Russian State Medical University City Hospital # 4
Moscow, RUS, 113093
Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
Moscow, RUS, 117036
Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47
Moscow, RUS, 117192
Russian State Medical University Central Clinical Hospital Russian Science Academy
Moscow, RUS, 117593
Sechenov Moscow Medical Academy
Moscow, RUS, 119881
Moscow Medical Academy
Moscow, RUS, 123478
Study site
Moscow, RUS, 125315
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
Moscow, RUS, 127644
Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology
Moscow, RUS, 129090
Moscow City Clinical Hospital # 20
Moscow, RUS, 129327
Municipal Clinical Hospital #13
Moscow, RUS, 150062
Nizhni Novgorod regional hospital na Semashko
Nizhny Novgorod, RUS, 603126
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
Saint Petersburg, RUS, 193012
Central Medical Sanitary Unit #122
Saint Petersburg, RUS, 194291
SPb Diabetological Center
Saint Petersburg, RUS, 194354
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
Saint Petersburg, RUS, 194354
St Petersburg Medical Academy St Elizabeth Hospital
Saint Petersburg, RUS, 195257
Pavlov State Medical Univ of St Petersburg
Saint Petersburg, RUS, 197022
City Outpatient Clinic # 34
Saint Petersburg, RUS, 197198
TUV Medico-Military Academy
Saint Petersburg, RUS, 198013
Center Diabetes LLC
Samara, RUS, 443067
Saratov City Outpatient Clinic # 20
Saratov, RUS, 410038
Saratov Medical University Faculty Therapy Chair Clinical Hospital # 3
Saratov, RUS, 410054
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
Smolensk, RUS, 214018
MHI Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, 150003
Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062
About this study
Official title: A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin
To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c >7.0% and <11.5%.
- Conditions
- Diabetes Type 2
- Being tested
- Technosphere Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
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.
Mean change in HbA1c from baseline to treatment week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startNov 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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
- 0 participants
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Baughman, PhD, Study director, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539890
- Sponsor's protocol ID
- MKC-TI-014
- Status last verified
- Oct 2009
- First submitted
- 3 Oct 2007
- Last updated
- 14 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin
- ClinicalTrials.gov ID
- NCT00539890
- Acronym / sponsor ID
- MKC-TI-014
- Conditions
- Diabetes Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 5 Oct 2007 (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.
To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c >7.0% and <11.5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 2 years since diagnosis of type 2 diabetes mellitus
- Received subcutaneous (sc) insulin for at least 3 months
- Body Mass Index <44 kg/m2
- HbA1c>7.0% and <11.5%
- Serum creatinine <2.0 mg/dL for males and <1.8 mg/dL for females
Key exclusion criteria (18 listed)
- Significant hepatic disease (AST/ALT3 x ULN)
- Diagnosis of Type 1 diabetes
- Severe complications of diabetes
- History of moderate to severe ketoacidosis within the past 3 months
- Upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days
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
Mean change in HbA1c from baseline to treatment week 24
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
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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.
Robert Baughman, PhD study director
Mannkind Corporation
33 sites in 1 country: 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 Type 2, run by Mannkind Corporation at 33 sites in Russia.
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 6 inclusion and 18 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 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Russia. 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 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?
Mean change in HbA1c from baseline to treatment week 24 (time frame: 24 weeks). 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 14 Oct 2009.