Diabetes Mellitus, Type 2Phase 3NCT00246623
US Inhaled Insulin Dose Titration Study
A Phase 3 study testing Exubera (inhaled insulin), 8-point glucose diary (to assess pre- and post prandial glucoses) and Meal Tolerance Test in people with Diabetes Mellitus, Type 2, run by Pfizer at 16 sites in United States.
Trial summary
This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exubera (inhaled insulin), 8-point glucose diary (to assess pre- and post prandial glucoses) and Meal Tolerance Test
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 16 sitesUnited States
- Study dates
- Nov 2005to Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, age >= 18 years and <= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10%
- Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones)
Who cannot join
- Type 1 diabetes
- Smoking within the past 6 months or significant pulmonary diseases
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Pfizer Investigational Site
Albany, New York
Pfizer Investigational Site
Atlanta, Georgia
Pfizer Investigational Site
Baton Rouge, Louisiana
Pfizer Investigational Site
Bennington, Vermont
Pfizer Investigational Site
Birmingham, Alabama
Pfizer Investigational Site
Boise, Idaho
Pfizer Investigational Site
Boston, Massachusetts
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
El Paso, Texas
Pfizer Investigational Site
Hayden, Idaho
Pfizer Investigational Site
Hollywood, Florida
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
New Britain, Connecticut
Pfizer Investigational Site
Norwalk, Connecticut
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
Syracuse, New York
About this study
Official title: A Randomized, Open-Label, Multicenter Study Assessing the Effects of Forced Exubera Dose Titration on Glycemic Control in Patients With Suboptimally Controlled Type 2 Diabetes on Two or More Oral Antidiabetic Agents
This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exubera (inhaled insulin), 8-point glucose diary (to assess pre- and post prandial glucoses), Meal Tolerance Test, 24-hour continuous glucose monitoring (at select sites), Pulmonary Function Testing
- 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.
Exubera (inhaled insulin)Drug
8-point glucose diary (to assess pre- and post prandial glucoses)Procedure or surgery
Meal Tolerance TestProcedure or surgery
24-hour continuous glucose monitoring (at select sites)Procedure or surgery
Pulmonary Function TestingProcedure or surgery
Hypoglycemic Event MonitoringProcedure or surgery
Laboratory AssessmentsProcedure or surgery
Nutritional Counseling and Diabetes EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months.
Secondary outcomes (1)
Secondary endpoints include change in A1C, fasting and 2 hr PP glucose, 24-hr mean glucose measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. Hypoglycemia will also be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startNov 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246623
- Sponsor's protocol ID
- A2171067
- Status last verified
- May 2007
- First submitted
- 28 Oct 2005
- Last updated
- 8 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Study Assessing the Effects of Forced Exubera Dose Titration on Glycemic Control in Patients With Suboptimally Controlled Type 2 Diabetes on Two or More Oral Antidiabetic Agents
- ClinicalTrials.gov ID
- NCT00246623
- Acronym / sponsor ID
- A2171067
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Nov 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 31 Oct 2005 (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.
This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.
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 (2 listed)
- Male and female, age >= 18 years and <= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10%
- Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones)
Key exclusion criteria (2 listed)
- Type 1 diabetes
- Smoking within the past 6 months or significant pulmonary diseases
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 |
|---|---|---|
| Exubera (inhaled insulin) | Drug | – |
| 8-point glucose diary (to assess pre- and post prandial glucoses) | Procedure or surgery | – |
| Meal Tolerance Test | Procedure or surgery | – |
| 24-hour continuous glucose monitoring (at select sites) | Procedure or surgery | – |
| Pulmonary Function Testing | Procedure or surgery | – |
| Hypoglycemic Event Monitoring | Procedure or surgery | – |
| Laboratory Assessments | Procedure or surgery | – |
| Nutritional Counseling and Diabetes Education | Behavioural | – |
Primary outcome
Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months.
1 secondary outcome
Secondary endpoints include change in A1C, fasting and 2 hr PP glucose, 24-hr mean glucose measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. Hypoglycemia will also be assessed.
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 8 Feb 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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
16 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 Exubera (inhaled insulin), 8-point glucose diary (to assess pre- and post prandial glucoses) and Meal Tolerance Test in people with Diabetes Mellitus, Type 2, run by Pfizer at 16 sites in United States.
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: finished, as of the sponsor's last update on 8 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 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?
Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months.. 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 8 Feb 2008.