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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02053116

Enrollment

Registered

2014-02-03

Start date

2014-03-31

Completion date

2014-04-30

Last updated

2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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).

Interventions

DRUGPF-05175157

Tablet, 200 mg, twice daily, 6 weeks

DRUGPlacebo

Tablet, 0 mg, twice daily, 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

* 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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo	Week 0, 4

Secondary

Measure	Time frame
Change from baseline in non-HDL cholesterol	Weeks 0, 4 and 6
Change from baseline in very low density lipoprotein (VLDL)	Weeks 0, 4 and 6
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
Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)	Weeks 0, 4 and 6
Change from baseline in triglycerides	Weeks 0, 4 and 6
Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT	Weeks 0, 4 and 6
Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT	Weeks 0, 4 and 6
Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)	Weeks 0, 4 and 6
Change from baseline in homeostatic model assessment for β-cell function (HOMA B)	Weeks 0, 4 and 6
Change from baseline in low density lipoprotein cholesterol (LDL-C)	Weeks 0, 4 and 6
Plasma concentrations for PF-05175157	Weeks 2, 4 and 6
Percent change from baseline in body weight	Weeks 0, 4 and 6
Change from baseline in high density lipoprotein cholesterol (HDL-C)	Weeks 0, 4 and 6
Change from baseline in C-peptide AUC(0-5) during mixed meal tolerance test (MMTT)	Weeks 0, 4 and 6

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026