Diabetes Mellitus, Type 1Phase 4NCT00356421

A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

A Phase 4 study testing Inhaled Human Insulin (Exubera®) and Insulin lispro (Humalog) in people with Diabetes Mellitus, Type 1, run by Pfizer at 23 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Inhaled Human Insulin (Exubera®) and Insulin lispro (Humalog)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 23 sitesin 13 countries
Study dates: Nov 2006to Jun 2008
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 1

Who cannot join

Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
Smoking

Trial locations and contacts

23 sites in 13 countries.

Country

City, postcode or hospital

23 sites in 13 countries

Belgium3 sites

Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Genk, 3600
Pfizer Investigational Site
Leuven, 3000

Other trials in Belgium

France3 sites

Pfizer Investigational Site
Brest, 29609
Pfizer Investigational Site
Corbeil-Essonnes, 91106
Pfizer Investigational Site
Strasbourg, 67091

Other trials in France

United Kingdom3 sites

Pfizer Investigational Site
Birmingham, West Midlands, B9 5SS
Pfizer Investigational Site
Bournemouth, Dorset, BH7 7DW
Pfizer Investigational Site
Dundee, Tayside, DD1 9SY

Other trials in United Kingdom

United States2 sites

Pfizer Investigational Site
Hamilton, New Jersey, 08610
Pfizer Investigational Site
New Brunswick, New Jersey, 08903

Other trials in United States

Austria2 sites

Pfizer Investigational Site
Vienna, A-1030
Pfizer Investigational Site
Vienna, A-1130

Other trials in Austria

Spain2 sites

Pfizer Investigational Site
Las Palmas, LAS Palmas de GRAN Canaria, 35016
Pfizer Investigational Site
Valencia, Valencia, 46010

Other trials in Spain

Sweden2 sites

Pfizer Investigational Site
Stockholm, 171 76
Pfizer Investigational Site
Stockholm, 182 88

Other trials in Sweden

Denmark1 site

Pfizer Investigational Site
Aarhus, 8000

Other trials in Denmark

Finland1 site

Pfizer Investigational Site
Kuopio, 70211

Other trials in Finland

Ireland1 site

Pfizer Investigational Site
Waterford

Other trials in Ireland

Netherlands1 site

Pfizer Investigational Site
Amsterdam, NL-1105 AZ

Other trials in Netherlands

Norway1 site

Pfizer Investigational Site
Stavanger, 4095

Other trials in Norway

Portugal1 site

Pfizer Investigational Site
Lisbon, 1349-019

Other trials in Portugal

About this study

Official title: A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus

To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

Read the detailed description

Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera®, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera®. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Conditions: Diabetes Mellitus, Type 1
Being tested: Inhaled Human Insulin (Exubera®), Insulin lispro (Humalog)
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inhaled Human Insulin (Exubera®)Drug
Preprandial inhaled insulin regimen and administration of insulin glargine QD
Insulin lispro (Humalog)Drug
Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.

Study groups in NCT00356421
Study group	Role	What they receive
Control	Active comparator	Not described Receives: Drug: Insulin lispro (Humalog)
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 From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At 52 weeks

Secondary outcomes (13)

Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At 52 weeks
Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At 52 weeks
Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.
Change From Baseline in FPG
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At 52 weeks or last observation
Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: To 52 weeks
Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: To 52 weeks
Change From Baseline in Insulin Antibody Levels
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At weeks 24 and 52 or last observation.
Change From Baseline in Body Weight
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At weeks 12, 24, 36, and 52 or last observation.
Change From Baseline in Body Mass Index
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At weeks 12, 24, 36, and 52 or last observation.
Change From Baseline in Basal Insulin Doses
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: To 52 weeks
Change From Baseline in Prandial Insulin Doses
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: To 52 weeks
Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: To 52 weeks.
Change in Fasting Lipids From Baseline
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Measured: At weeks 24 and 52 or last observation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Jun 2008

First posted26 Jul 2006 (estimated)
Study startNov 2006
Primary completionJun 2008
Study completionJun 2008

Why it stopped: See termination reason in detailed description.

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 1Studies 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: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00356421
Sponsor's protocol ID: A2171035
Status last verified: Jan 2009
First submitted: 24 Jul 2006
Last updated: 2 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00356421
Acronym / sponsor ID: A2171035
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 58 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 26 Jul 2006 (estimated)
Results: Posted 11 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

Detailed description

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: Insulin lispro (Humalog)
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 (1 listed)

Diabetes mellitus Type 1

Key exclusion criteria (2 listed)

Severe Asthma, severe Chronic Obstructive Pulmonary Disease (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®)Preprandial inhaled insulin regimen and administration of insulin glargine QD	Drug	Experimental
Insulin lispro (Humalog)Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.	Drug	Control

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)
Time frame: At 52 weeks
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.

13 secondary outcomes

Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%
Time frame: At 52 weeks
Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%
Time frame: At 52 weeks
Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline
Time frame: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.
Change From Baseline in FPG
Time frame: At 52 weeks or last observation
Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments
Time frame: To 52 weeks
Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments
Time frame: To 52 weeks
Change From Baseline in Insulin Antibody Levels
Time frame: At weeks 24 and 52 or last observation.
Change From Baseline in Body Weight
Time frame: At weeks 12, 24, 36, and 52 or last observation.
Change From Baseline in Body Mass Index
Time frame: At weeks 12, 24, 36, and 52 or last observation.
Change From Baseline in Basal Insulin Doses
Time frame: To 52 weeks
Change From Baseline in Prandial Insulin Doses
Time frame: To 52 weeks
Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)
Time frame: To 52 weeks.
Change in Fasting Lipids From Baseline
Time frame: At weeks 24 and 52 or last observation

Results and safety

Results posted to the registry on 11 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exubera ®	38	6
Insulin Lispro	20	3

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)

Time frame: At 52 weeks. Number. Unit: percent

Population analysed: Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exubera ®	2 of ?	35 of ?	Not reported
Insulin Lispro	1 of ?	20 of ?	Not reported

Limitations and caveats (from the sponsor): As a result of Pfizer's decision to stop marketing Exubera ®, this study was terminated. Due to the early termination of the study and the low number of subjects who completed, no descriptive statistics for efficacy endpoints are provided.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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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RecruitingPhase 1
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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

23 sites in 13 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®) and Insulin lispro (Humalog) in people with Diabetes Mellitus, Type 1, run by Pfizer at 23 sites in 13 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 1 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 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Belgium, France, United Kingdom, United States, Austria and 8 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 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 11 Aug 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 From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) (time frame: At 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356421.

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 2 Sep 2009.