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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: PF-05175157; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02053116

B1731006

Details and patient eligibility

About

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).

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups, including a placebo group

PF-05175157

Experimental group

Treatment:

Drug: PF-05175157

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo