Type 2 Diabetes PatientsPhase 1NCT01298518
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
A Phase 1 study testing PF-04620110 in people with Type 2 Diabetes Patients, run by Pfizer at 3 sites in United States.
Trial summary
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Patients
- What is being tested?
- PF-04620110
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2011to May 2011
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and/or female subjects between the ages of 18 and 60 years;
- Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
- Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
- Subjects who have been on well-tolerated and stable doses of metformin
Who cannot join
- Recent evidence (6 months prior to screening) or history of unstable major organ disease;
- Diagnosis of Type 1 diabetes mellitus;
- Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
- Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Chula Vista, California, 91911
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Miami Gardens, Florida, 33169
About this study
Official title: A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
- Conditions
- Type 2 Diabetes Patients
- Being tested
- PF-04620110, Placebo
- Keywords
- multiple dose study in type 2 diabetes patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04620110Drug
5 mg of PF-04620110 given once daily
PF-04620110Drug
2.5 mg of PF-04620110 given twice daily
PlaceboDrug
Matching placebo giving for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| PF-04620110 | Experimental | Not described Receives: Drug: PF-04620110 |
| 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 Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Measured: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Secondary outcomes (16)
Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28
APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.
Measured: Baseline (Day -1); 24 hours post-dose on Day 28
Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Measured: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Measured: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Measured: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.
Measured: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.
Measured: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.
Measured: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Fasting Glucose at Day 28
Measured: 0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Insulin at Day 28
Measured: 0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Net Triglycerides at Day 28
Measured: 0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28
Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
Measured: Baseline (Day -1); 6 to 10 hours post-dose on Day 28
Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28
Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
Measured: Baseline (Day -1); 12 to 16 hours post-dose on Day 28
Maximum Observed Plasma Concentration (Cmax) of PF-04620110
Measured: 24 hours post-morning dose on Day 28
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110
Measured: 24 hours post-morning dose on Day 28
Time to Cmax (Tmax) of PF-04620110
Measured: 24 hours post-morning dose on Day 28
Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110
Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.
AUC (0-24) was computed using the linear trapezoidal method.
Measured: 24 hours post-morning dose on Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionMay 2011
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 Type 2 Diabetes PatientsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298518
- Sponsor's protocol ID
- B0961007
- Status last verified
- Oct 2012
- First submitted
- 28 Jan 2011
- Last updated
- 6 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin
- ClinicalTrials.gov ID
- NCT01298518
- Acronym / sponsor ID
- B0961007
- Conditions
- Type 2 Diabetes Patients
- Keywords
- multiple dose study in type 2 diabetes patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Posted 6 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04620110 | Experimental | Drug: PF-04620110 |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and/or female subjects between the ages of 18 and 60 years;
- Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
- Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
- Subjects who have been on well-tolerated and stable doses of metformin
Key exclusion criteria (4 listed)
- Recent evidence (6 months prior to screening) or history of unstable major organ disease;
- Diagnosis of Type 1 diabetes mellitus;
- Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
- Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;
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-046201105 mg of PF-04620110 given once daily | Drug | PF-04620110 |
| PF-046201102.5 mg of PF-04620110 given twice daily | Drug | PF-04620110 |
| PlaceboMatching placebo giving for 4 weeks | Drug | placebo |
Primary outcome
Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Time frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
16 secondary outcomes
Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28
Time frame: Baseline (Day -1); 24 hours post-dose on Day 28
Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Time frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Time frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Time frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Time frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Time frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Time frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Fasting Glucose at Day 28
Time frame: 0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Insulin at Day 28
Time frame: 0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Net Triglycerides at Day 28
Time frame: 0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28
Time frame: Baseline (Day -1); 6 to 10 hours post-dose on Day 28
Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28
Time frame: Baseline (Day -1); 12 to 16 hours post-dose on Day 28
Maximum Observed Plasma Concentration (Cmax) of PF-04620110
Time frame: 24 hours post-morning dose on Day 28
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110
Time frame: 24 hours post-morning dose on Day 28
Time to Cmax (Tmax) of PF-04620110
Time frame: 24 hours post-morning dose on Day 28
Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110
Time frame: 24 hours post-morning dose on Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-04620110 in people with Type 2 Diabetes Patients, run by Pfizer at 3 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 4 inclusion and 4 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 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Nov 2012). 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 Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 (time frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28). 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 6 Nov 2012.