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

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).

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: PF-05175157; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • DeLand, Florida, United States, 32720
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Tablet, 0 mg, twice daily, 2 weeks
Experimental: PF-05175157	Drug: PF-05175157; Tablet, 200 mg, twice daily, 6 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 C-peptide AUC(0-5) during mixed meal tolerance test (MMTT)	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 triglycerides	Weeks 0, 4 and 6
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: B1731006