Diabetes Mellitus, Type 2Phase 2NCT01338870

Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

A Phase 2 study testing 25 mg PF-04991532, 75 mg PF-04991532 and 150 mg PF-04991532 in people with Diabetes Mellitus, Type 2, run by Pfizer at 42 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: 25 mg PF-04991532, 75 mg PF-04991532 and 150 mg PF-04991532
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 301 participants
Where: 42 sitesin 6 countries
Study dates: Jun 2011to Mar 2012
Phase: Phase 2
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Who cannot join

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

Trial locations and contacts

42 sites in 6 countries.

Country

City, postcode or hospital

42 sites in 6 countries

United States25 sites

Pfizer Investigational Site
Auburn, Maine, 04210
Pfizer Investigational Site
Augusta, Kansas, 67010
Pfizer Investigational Site
Brooklyn Center, Minnesota, 55430
Pfizer Investigational Site
Charlotte, North Carolina, 28277
Pfizer Investigational Site
Cincinnati, Ohio, 45245
Pfizer Investigational Site
Coral Gables, Florida, 33134
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Denver, Colorado, 80209
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Katy, Texas, 77450
Pfizer Investigational Site
Lake Charles, Louisiana, 70601
Pfizer Investigational Site
Lansdale, Pennsylvania, 19446
Pfizer Investigational Site
Las Vegas, Nevada, 89101
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Roseville, California, 95661
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Trenton, New Jersey, 08611
Pfizer Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Canada6 sites

Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0
Pfizer Investigational Site
Brampton, Ontario, L6T 0G1
Pfizer Investigational Site
Mirabel, Quebec, J7J 2K8
Pfizer Investigational Site
Mississauga, Ontario, L4Y 2N8
Pfizer Investigational Site
Québec, Quebec, G3K 2P8
Pfizer Investigational Site
Surrey, British Columbia, V4A 2H9

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Slovakia4 sites

Pfizer Investigational Site
Bratislava, 851 01
Pfizer Investigational Site
Nové Mesto nad Váhom, 915 01
Pfizer Investigational Site
Pezinok, 902 01
Pfizer Investigational Site
Prešov, 080 01

Other trials in Slovakia

Mexico3 sites

Pfizer Investigational Site
Aguascalientes, Aguascalientes, 20234
Pfizer Investigational Site
Mexico City, Mexico City, 06700
Pfizer Investigational Site
Tlalnepantla, State of Mexico, 54055

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Hungary2 sites

Pfizer Investigational Site
Balatonfüred, 8230
Pfizer Investigational Site
Kistelek, 6760

Other trials in Hungary

Taiwan2 sites

Pfizer Investigational Site
Taichung, 40705
Pfizer Investigational Site
Taoyuan County, 333

Other trials in Taiwan

About this study

Official title: A 12-week, Phase 2, Randomized, Double-blind, Placebo Controlled, Dose-ranging, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Pf-04991532 and Once Daily Sitagliptin in Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, 25 mg PF-04991532, 75 mg PF-04991532, 150 mg PF-04991532, 300 mg PF-04991532
Keywords: Phase 2, safety and efficacy study with PF-04991532, Type 2 diabetes
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.

PlaceboDrug
Tablets (n=4), 0 mg twice daily for 84 days
25 mg PF-04991532Drug
Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days
75 mg PF-04991532Drug
Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days
150 mg PF-04991532Drug
Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days
300 mg PF-04991532Drug
Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days
Sitagliptin 100 mgDrug
Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.

Study groups in NCT01338870
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo for PF-04991532 and sitagliptin Receives: Drug: Placebo
25 mg PF-04991532	Experimental	Not described Receives: Drug: 25 mg PF-04991532
75 mg PF-04991532	Experimental	Not described Receives: Drug: 75 mg PF-04991532
150 mg PF-04991532	Experimental	Not described Receives: Drug: 150 mg PF-04991532
300 mg PF-04991532	Experimental	Not described Receives: Drug: 300 mg PF-04991532
Sitagliptin 100 mg	Active comparator	Not described Receives: Drug: Sitagliptin 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Measured: Baseline, Week 12

Secondary outcomes (6)

Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Measured: Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Measured: Baseline, Week 1, 2, 4, 8
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes, and levels of 6.5% or higher indicate diabetes.
Measured: Week 12
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.
Measured: Baseline, Week 1, 2, 4, 8, 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline
Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight from baseline signifies a higher risk of diabetes.
Measured: Week 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline
The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% loss in body weight from baseline signifies an improvement of glycemia.
Measured: Week 12

Timeline

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

Jun 2011Mar 2012

First posted20 Apr 2011 (estimated)
Study startJun 2011
Primary completionMar 2012
Study completionMar 2012

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01338870
Sponsor's protocol ID: B2611003
Status last verified: Mar 2013
First submitted: 13 Apr 2011
Last updated: 23 Apr 2013
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?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week, Phase 2, Randomized, Double-blind, Placebo Controlled, Dose-ranging, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Pf-04991532 and Once Daily Sitagliptin in Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
ClinicalTrials.gov ID: NCT01338870
Acronym / sponsor ID: B2611003
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 2, safety and efficacy study with PF-04991532, Type 2 diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 20 Apr 2011 (estimated)
Results: Posted 23 Apr 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo for PF-04991532 and sitagliptin
25 mg PF-04991532	Experimental	Drug: 25 mg PF-04991532
75 mg PF-04991532	Experimental	Drug: 75 mg PF-04991532
150 mg PF-04991532	Experimental	Drug: 150 mg PF-04991532
300 mg PF-04991532	Experimental	Drug: 300 mg PF-04991532
Sitagliptin 100 mg	Active comparator	Drug: Sitagliptin 100 mg

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Key exclusion criteria (1 listed)

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

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
PlaceboTablets (n=4), 0 mg twice daily for 84 days	Drug	Placebo
25 mg PF-04991532Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days	Drug	25 mg PF-04991532
75 mg PF-04991532Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days	Drug	75 mg PF-04991532
150 mg PF-04991532Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days	Drug	150 mg PF-04991532
300 mg PF-04991532Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days	Drug	300 mg PF-04991532
Sitagliptin 100 mgTablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.	Drug	Sitagliptin 100 mg

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Time frame: Baseline, Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.

6 secondary outcomes

Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Time frame: Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Time frame: Baseline, Week 1, 2, 4, 8
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
Time frame: Week 12
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Time frame: Baseline, Week 1, 2, 4, 8, 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline
Time frame: Week 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline
Time frame: Week 12

Results and safety

Results posted to the registry on 23 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	50	41
PF-04991532 25 mg	49	37
PF-04991532 75 mg	50	39
PF-04991532 150 mg	50	41
PF-04991532 300 mg	52	46
Sitagliptin 100 mg	50	44

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: percentage of hemoglobin

Measure	Placebo n = 50	PF-04991532 25 mg n = 49	PF-04991532 75 mg n = 50	PF-04991532 150 mg n = 50	PF-04991532 300 mg n = 52	Sitagliptin 100 mg n = 50
Baseline (n= 50, 49, 50, 50, 52, 50)	8.11 (1.255)	7.90 (0.939)	7.86 (0.998)	7.93 (1.018)	8.01 (1.064)	8.05 (0.958)
Change at Week 12 (n= 42, 37, 39, 40, 46, 44)	-0.30 (0.681)	-0.15 (0.593)	-0.51 (0.847)	-0.36 (0.828)	-0.79 (0.743)	-0.65 (0.754)

Placebo vs PF-04991532 25 mg: Least squares (LS) mean difference: 0.10 (80% CI -0.08 to 0.29), p = 0.7606, Mixed Models Analysis
Placebo vs PF-04991532 75 mg: LS mean difference: -0.28 (80% CI -0.46 to -0.09), p = 0.0266, Mixed Models Analysis
Placebo vs PF-04991532 150 mg: LS mean difference: -0.24 (80% CI -0.42 to -0.06), p = 0.0440, Mixed Models Analysis

Population analysed: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 50 (0%)	14 of 50 (28%)	Not reported
PF-04991532 25 mg	0 of 49 (0%)	16 of 49 (32.7%)	Not reported
PF-04991532 75 mg	0 of 50 (0%)	14 of 50 (28%)	Not reported
PF-04991532 150 mg	0 of 50 (0%)	11 of 50 (22%)	Not reported
PF-04991532 300 mg	0 of 52 (0%)	15 of 52 (28.8%)	Not reported
Sitagliptin 100 mg	0 of 50 (0%)	11 of 50 (22%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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

42 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 25 mg PF-04991532, 75 mg PF-04991532 and 150 mg PF-04991532 in people with Diabetes Mellitus, Type 2, run by Pfizer at 42 sites in 6 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 1 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 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada, Slovakia, Mexico, Hungary and 1 more country. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Apr 2013). 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) at Week 12 (time frame: Baseline, Week 12). 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 NCT01338870.

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 23 Apr 2013.