Study 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.
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin
A 6-week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 Administered With Canagliflozin In Adult Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
8
1 country
1
Brief Summary
A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks, with canagliflozin, in adult subjects with Type 2 Diabetes Mellitus (T2DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started Mar 2014
Shorter than P25 for phase_2 type-2-diabetes-mellitus
1 active site
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
CompletedFirst Posted
Study publicly available on registry
February 3, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 2, 2016
May 1, 2014
1 month
January 30, 2014
March 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
Week 0, 4
Secondary Outcomes (18)
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
- +13 more secondary outcomes
Study Arms (2)
PF-05175157
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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 and are willing to switch to canagliflozin from metformin for the duration of the study
- 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
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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