Type 2 Diabetes MellitusPhase 2NCT02053103

A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin

A Phase 2 study testing PF-05175157 in people with Type 2 Diabetes Mellitus, run by Pfizer at 1 site in United States.

Terminated

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

Trial summary

A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: PF-05175157
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Apr 2014
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months
Hemoglobin A1c of 7-10% at screening.
Body Mass Index of at least 25 kg/m2.

Who cannot join

Compliant with study drug administration during the run-in period and throughout the trial.
Patients with fasting triglycerides greater than 500 mg/dL at screening.
History of certain diabetic complications or cardiac problems.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 In Adult Subjects With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Conditions: Type 2 Diabetes Mellitus
Being tested: PF-05175157, Placebo
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.

PF-05175157Drug
Tablet, 200 mg, twice daily, 6 weeks
PlaceboDrug
Tablet, 0 mg, twice daily, 6 weeks

Study groups in NCT02053103
Study group	Role	What they receive
PF-05175157	Experimental	Not described Receives: Drug: PF-05175157
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
Measured: Baseline, Day 42

Secondary outcomes (17)

Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
Measured: Weeks 0 and 4
Change from baseline in fasting plasma glucose
Measured: Weeks 0, 2, 4 and 6
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Measured: Weeks 0, 4 and 6
Change from baseline in fasting total cholesterol
Measured: Weeks 0, 4 and 6
Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)
Measured: Weeks 0, 4 and 6
Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)
Measured: Weeks 0, 4 and 6
Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT
Measured: Weeks 0, 4 and 6
Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT
Measured: Weeks 0, 4 and 6
Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)
Measured: Weeks 0, 4 and 6
Change from baseline in homeostatic model assessment for β-cell function (HOMA B)
Measured: Weeks 0, 4 and 6
Plasma concentrations for PF-05175157
Measured: Weeks 2, 4 and 6
Percent change from baseline in body weight
Measured: Weeks 0, 4 and 6
Change from baseline in low density lipoprotein cholesterol (LDL-C)
Measured: Weeks 0, 4 and 6
Change from baseline in high density lipoprotein cholesterol (HDL-C)
Measured: Weeks 0, 4 and 6
Change from baseline in triglycerides
Measured: Weeks 0, 4 and 6
Change from baseline in non-HDL cholesterol
Measured: Weeks 0, 4 and 6
Change from baseline in very low density lipoprotein (VLDL)
Measured: Weeks 0, 4 and 6

Timeline

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

Mar 2014Apr 2014

First posted3 Feb 2014 (estimated)
Study startMar 2014
Primary completionApr 2014
Study completionApr 2014

Why it stopped: On 25April2014, study was terminated before any dosing due to an AE of safety concern that occurred in protocol B1731003 with the same drug.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02053103
Sponsor's protocol ID: B1731002
Status last verified: May 2014
First submitted: 30 Jan 2014
Last updated: 2 May 2016
Results posted: No
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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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
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A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 In Adult Subjects With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
ClinicalTrials.gov ID: NCT02053103
Acronym / sponsor ID: B1731002
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: On 25April2014, study was terminated before any dosing due to an AE of safety concern that occurred in protocol B1731003 with the same drug.
Enrolment: 13 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 3 Feb 2014 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PF-05175157	Experimental	Drug: PF-05175157
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months
Hemoglobin A1c of 7-10% at screening.
Body Mass Index of at least 25 kg/m2.

Key exclusion criteria (3 listed)

Compliant with study drug administration during the run-in period and throughout the trial.
Patients with fasting triglycerides greater than 500 mg/dL at screening.
History of certain diabetic complications or cardiac problems.

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
PF-05175157Tablet, 200 mg, twice daily, 6 weeks	Drug	PF-05175157
PlaceboTablet, 0 mg, twice daily, 6 weeks	Drug	Placebo

Primary outcome

Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
Time frame: Baseline, Day 42

17 secondary outcomes

Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
Time frame: Weeks 0 and 4
Change from baseline in fasting plasma glucose
Time frame: Weeks 0, 2, 4 and 6
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Weeks 0, 4 and 6
Change from baseline in fasting total cholesterol
Time frame: Weeks 0, 4 and 6
Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)
Time frame: Weeks 0, 4 and 6
Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)
Time frame: Weeks 0, 4 and 6
Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT
Time frame: Weeks 0, 4 and 6
Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT
Time frame: Weeks 0, 4 and 6
Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)
Time frame: Weeks 0, 4 and 6
Change from baseline in homeostatic model assessment for β-cell function (HOMA B)
Time frame: Weeks 0, 4 and 6
Plasma concentrations for PF-05175157
Time frame: Weeks 2, 4 and 6
Percent change from baseline in body weight
Time frame: Weeks 0, 4 and 6
Change from baseline in low density lipoprotein cholesterol (LDL-C)
Time frame: Weeks 0, 4 and 6
Change from baseline in high density lipoprotein cholesterol (HDL-C)
Time frame: Weeks 0, 4 and 6
Change from baseline in triglycerides
Time frame: Weeks 0, 4 and 6
Change from baseline in non-HDL cholesterol
Time frame: Weeks 0, 4 and 6
Change from baseline in very low density lipoprotein (VLDL)
Time frame: Weeks 0, 4 and 6

Results and safety

The study was stopped early (reason given: On 25April2014, study was terminated before any dosing due to an AE of safety concern that occurred in protocol B1731003 with the same drug.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Type 2 Diabetes Mellitus

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-05175157 in people with Type 2 Diabetes Mellitus, run by Pfizer at 1 site 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 3 inclusion and 3 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 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

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 Weighted Mean Daily Glucose (WMDG) when compared to placebo (time frame: Baseline, Day 42). 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 NCT02053103.

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 May 2016.