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

Phase 2

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: PF-05175157

• Registration Number: NCT02053116
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Study Start: 2014-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Disposition First Submitted: 2016-03-29
• Disposition First Submitted QC: 2016-03-29
• Last Update Submitted: 2016-03-29
• Disposition First Posted: 2016-05-02
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PF-05175157	PF-05175157	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)	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 total cholesterol	Weeks 0, 4 and 6
Change from baseline in very low density lipoprotein (VLDL)	Weeks 0, 4 and 6
Plasma concentrations for PF-05175157	Weeks 2, 4 and 6
Change from baseline in triglycerides	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) 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
Percent change from baseline in body weight	Weeks 0, 4 and 6
Change from baseline in fasting plasma glucose	Weeks 0, 2, 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 low density lipoprotein cholesterol (LDL-C)	Weeks 0, 4 and 6
Change from baseline in Glycosylated Hemoglobin (HbA1c)	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 homeostatic model assessment for β-cell function (HOMA B)	Weeks 0, 4 and 6
Change from baseline in high density lipoprotein cholesterol (HDL-C)	Weeks 0, 4 and 6
Change from baseline in non-HDL cholesterol	Weeks 0, 4 and 6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 DeLand, Florida, United States