NCT02053103

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

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 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 2, 2016

Status Verified

May 1, 2014

Enrollment Period

1 month

First QC Date

January 30, 2014

Last Update Submit

March 29, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo

    Baseline, Day 42

Secondary Outcomes (17)

  • Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo

    Weeks 0 and 4

  • Change from baseline in fasting plasma glucose

    Weeks 0, 2, 4 and 6

  • Change from baseline in Glycosylated Hemoglobin (HbA1c)

    Weeks 0, 4 and 6

  • Change from baseline in fasting total cholesterol

    Weeks 0, 4 and 6

  • Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)

    Weeks 0, 4 and 6

  • +12 more secondary outcomes

Study Arms (2)

PF-05175157

EXPERIMENTAL
Drug: PF-05175157

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-05175157DRUG

Tablet, 200 mg, twice daily, 6 weeks

PF-05175157
PlaceboDRUG

Tablet, 0 mg, twice daily, 6 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Orlando, Florida, 32809, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 3, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 2, 2016

Record last verified: 2014-05

Locations

US(1)