NCT01298518

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 6, 2012

Completed
Last Updated

November 6, 2012

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

January 28, 2011

Results QC Date

October 5, 2012

Last Update Submit

October 5, 2012

Conditions

Type 2 Diabetes Patients

Keywords

multiple dose study in type 2 diabetes patients

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    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

    Baseline (Day -1); 2 to 6 hours post-dose on Day 28

  • +11 more secondary outcomes

Study Arms (2)

PF-04620110

EXPERIMENTAL
Drug: PF-04620110

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04620110DRUG

5 mg of PF-04620110 given once daily

PF-04620110
PlaceboDRUG

Matching placebo giving for 4 weeks

placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Chula Vista, California, 91911, United States

Location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Pfizer Investigational Site

Miami Gardens, Florida, 33169, United States

Location

Related Links

MeSH Terms

Interventions

PF-04620110

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

February 17, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 6, 2012

Results First Posted

November 6, 2012

Record last verified: 2012-10

Locations

US(3)