Diabetes Mellitus, Type 2Phase 4NCT00437489
A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.
A Phase 4 study testing Inhaled Human Insulin (Exubera) in people with Diabetes Mellitus, Type 2, run by Pfizer at 9 sites in 4 countries.
Trial summary
The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Inhaled Human Insulin (Exubera)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Jun 2007to Dec 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus Type 2
- Currently treated with at least 2 oral anti-diabetic agents
Who cannot join
- Severe Asthma, severe COPD
- Smoking
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Philippines5 sites
Pfizer Investigational Site
Makati, 1218
Pfizer Investigational Site
Marikina City, 1810
Pfizer Investigational Site
Pasay, 1300
Pfizer Investigational Site
Pasig, 1605
Pfizer Investigational Site
Quezon City, 1102
Singapore2 sites
Pfizer Investigational Site
Singapore, 119074
Pfizer Investigational Site
Singapore, 159964
About this study
Official title: A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents.
The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Inhaled Human Insulin (Exubera)
- 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.
Inhaled Human Insulin (Exubera)Drug
Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
Inhaled Human Insulin (Exubera)Drug
Initial dose of 1mg TID of inhaled human insulin
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Drug: Inhaled Human Insulin (Exubera) |
| Experimental | Experimental | Not described Receives: Drug: Inhaled Human Insulin (Exubera) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c From Baseline
Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16
Measured: From baseline to week 16
Secondary outcomes (3)
Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)
Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.
Measured: From baseline to week 16
Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia
Cumulative Number Subjects Who Experienced Hypoglycemia \& Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.
Measured: week 16
Hypoglycemia Event Rate Per Month
Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).
Measured: up to week 4 or 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: This protocol was terminated not for safety reasons, but because Pfizer decided to return the worldwide rights for Exubera to Nektar, on 18 October 2007.
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 2Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437489
- Sponsor's protocol ID
- A2171086
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2007
- Last updated
- 11 May 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents.
- ClinicalTrials.gov ID
- NCT00437489
- Acronym / sponsor ID
- A2171086
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This protocol was terminated not for safety reasons, but because Pfizer decided to return the worldwide rights for Exubera to Nektar, on 18 October 2007.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Feb 2007 (estimated)
- Results
- Posted 6 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Inhaled Human Insulin (Exubera) |
| Experimental | Experimental | Drug: Inhaled Human Insulin (Exubera) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes mellitus Type 2
- Currently treated with at least 2 oral anti-diabetic agents
Key exclusion criteria (2 listed)
- Severe Asthma, severe COPD
- Smoking
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 |
|---|---|---|
| Inhaled Human Insulin (Exubera)Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID | Drug | Control |
| Inhaled Human Insulin (Exubera)Initial dose of 1mg TID of inhaled human insulin | Drug | Experimental |
Primary outcome
Change in HbA1c From Baseline
Time frame: From baseline to week 16
Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16
3 secondary outcomes
Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)
Time frame: From baseline to week 16
Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia
Time frame: week 16
Hypoglycemia Event Rate Per Month
Time frame: up to week 4 or 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhaled Human Insulin (Exubera) in people with Diabetes Mellitus, Type 2, run by Pfizer at 9 sites in 4 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 2 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: stopped early, as of the sponsor's last update on 11 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Philippines, Singapore, Hong Kong, Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Mar 2009). 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?
Change in HbA1c From Baseline (time frame: From baseline to week 16). 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 11 May 2009.