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TerminatedNCT02053116Updated May 2, 2016

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 Phase 2 interventional study of PF-05175157 and Placebo in Type 2 Diabetes Mellitus, sponsored by Pfizer. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by Pfizer · Phase 2, Interventional, and Basic science

Why this study was terminated
On 25April2014, study was terminated before any dosing due to an AE of safety concern that occurred in protocol B1731003 with the same drug.
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 8 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    PF-05175157

    Drug: PF-05175157

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugPF-05175157

    Tablet, 200 mg, twice daily, 6 weeks

  • DrugPlacebo

    Tablet, 0 mg, twice daily, 2 weeks

06

What researchers measure

Primary outcomes

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

    Time frame: Week 0, 4

Secondary outcomes

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

    Time frame: Weeks 0 and 4

  2. Change from baseline in fasting plasma glucose

    Time frame: Weeks 0, 2, 4 and 6

  3. Change from baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: Weeks 0, 4 and 6

  4. Change from baseline in fasting total cholesterol

    Time frame: Weeks 0, 4 and 6

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

    Time frame: Weeks 0, 4 and 6

  6. Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)

    Time frame: Weeks 0, 4 and 6

  7. Change from baseline in C-peptide AUC(0-5) during mixed meal tolerance test (MMTT)

    Time frame: Weeks 0, 4 and 6

  8. 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

  9. 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

  10. Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)

    Time frame: Weeks 0, 4 and 6

  11. Change from baseline in homeostatic model assessment for β-cell function (HOMA B)

    Time frame: Weeks 0, 4 and 6

  12. Change from baseline in low density lipoprotein cholesterol (LDL-C)

    Time frame: Weeks 0, 4 and 6

  13. Plasma concentrations for PF-05175157

    Time frame: Weeks 2, 4 and 6

  14. Percent change from baseline in body weight

    Time frame: Weeks 0, 4 and 6

  15. Change from baseline in high density lipoprotein cholesterol (HDL-C)

    Time frame: Weeks 0, 4 and 6

  16. Change from baseline in triglycerides

    Time frame: Weeks 0, 4 and 6

  17. Change from baseline in non-HDL cholesterol

    Time frame: Weeks 0, 4 and 6

  18. Change from baseline in very low density lipoprotein (VLDL)

    Time frame: Weeks 0, 4 and 6

07

Study locations

1 site
  • Pfizer Investigational Site
    DeLand, Florida 32720, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02053116
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 3, 2014
Start date
Mar 2014
Primary completion
Apr 2014
Completion
Apr 2014
Last update
May 2, 2016

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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