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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT02053116

Run by

Pfizer

People needed

8

Starts

2014-03-01

Expected to finish

2014-04-01

Last updated by the study team

2016-05-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — DeLand, Florida, United States

Full record on ClinicalTrials.gov

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