Diabetes MellitusNCT00642681
Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge
An observational study of Diabetes Mellitus and Upper Respiratory Infection, run by Mannkind Corporation at 24 sites in 3 countries.
Trial summary
Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Upper Respiratory Infection
- What is being tested?
- Technosphere Insulin
- How many people
- 20 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Dec 2007to Aug 2008
- Phase
- Observational
- 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
Study population: Subjects who developed symptoms of URI at any point during the MKC-TI-030 trial and were randomized to study treatment of TI
Who may be able to join
- Subjects will have met the same inclusion criteria as MKC-TI-030
- Clinical diagnosis of URI with in 24 hrs prior to clinic visit and/or day of clinic visit
- At least 3 URI symptoms
Who cannot join
- Prior participation in MKC-TI-112
- MedHist, PE or lab findings of acute bacterial infection including but not limited to sputum prod., nasal/eye discharge, chest exam abnormalities, CXR findings of pneumonia.
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States15 sites
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106
MODEL Clinical Research
Baltimore, Maryland, 21204
Billings Clinic Research Division
Billings, Montana, 59101
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Rapid Medical Research Inc
Cleveland, Ohio, 44122
Private Practice
Decatur, Georgia, 30035
Healthcare Research
Florissant, Missouri, 63031
Valley Research (Norwood)
Fresno, California
Diabetes/Lipid Management and Research Center
Huntington Beach, California, 92648
Magna Center for Family Medicine
Magna, Utah, 84044
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, 44060
M.E.R.I.
New York, New York, 10023
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229
Arizona Research Associates
Tuscon, Arizona, 85712
Russia8 sites
Kemerovo State Medical Academy of Ministry of Health
Kemerovo, RUS, 650061
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, 650061
Russian State Medical University City Hospital # 4
Moscow, RUS, 113093
RAAMS Endocrinology and Diabetology Department
Moscow, RUS, 125315
FSI Principal Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defense
Moscow, 105229
Clinical Pharm Dept of Yaroslavl Clin Hospital
Yaroslavl, RUS, 150003
NHI Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062
Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062
About this study
Official title: Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of Technosphere®/Insulin in Subjects With Diabetes Mellitus After a Meal Challenge
Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge
- Conditions
- Diabetes Mellitus, Upper Respiratory Infection
- Being tested
- Technosphere Insulin
- Medical subject headings
- Diabetes Mellitus, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere InsulinDrug
Technosphere® Insulin (TI) Inhalation Powder, prandial
| Study group | Role | What they receive |
|---|---|---|
| 1: TI Inhalation Powder | Technosphere® Insulin (TI) Inhalation Powder Receives: Drug: Technosphere Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure Serum FDKP AUC
Measured: 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642681
- Sponsor's protocol ID
- MKC-TI-112
- Status last verified
- Dec 2014
- First submitted
- 21 Mar 2008
- Last updated
- 3 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of Technosphere®/Insulin in Subjects With Diabetes Mellitus After a Meal Challenge
- ClinicalTrials.gov ID
- NCT00642681
- Acronym / sponsor ID
- MKC-TI-112
- Conditions
- Diabetes Mellitus, Upper Respiratory Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 25 Mar 2008 (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.
Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: TI Inhalation Powder | – | Drug: Technosphere InsulinTechnosphere® Insulin (TI) Inhalation Powder |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who developed symptoms of URI at any point during the MKC-TI-030 trial and were randomized to study treatment of TI
Key inclusion criteria (3 listed)
- Subjects will have met the same inclusion criteria as MKC-TI-030
- Clinical diagnosis of URI with in 24 hrs prior to clinic visit and/or day of clinic visit
- At least 3 URI symptoms
Key exclusion criteria (2 listed)
- Prior participation in MKC-TI-112
- MedHist, PE or lab findings of acute bacterial infection including but not limited to sputum prod., nasal/eye discharge, chest exam abnormalities, CXR findings of pneumonia.
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 InsulinTechnosphere® Insulin (TI) Inhalation Powder, prandial | Drug | 1: TI Inhalation Powder |
Primary outcome
To measure Serum FDKP AUC
Time frame: 4 Hours
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 3 Dec 2014.
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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.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Upper Respiratory Infection, run by Mannkind Corporation at 24 sites in 3 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 3 inclusion and 2 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Russia, Canada. 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.
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?
To measure Serum FDKP AUC (time frame: 4 Hours). 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 3 Dec 2014.