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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Canagliflozin

Criteria

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.