NCT01483781

A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus

A Double-Blind, Placebo-Controlled, Randomized, Parallel-Groups Study to Investigate the Effects of JNJ-28431754 (Canagliflozin) on Plasma Volume and Renal Function in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure.

Detailed description

This is a double-blind (neither the patient or study staff will know the identity of the treatment assigned) in patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic (blood sugar) control on metformin monotherapy (metformin taken alone for control of T2DM) and who are currently being treated for hypertension (high blood pressure) with agents called angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). In the study, patients will be randomized (assigned by chance) to receive treatment with canagliflozin or a placebo (a treatment identical in appearance to canagliflozin but does not contain active drug) for 12 weeks. During the 12-week treatment period, patients will also take metformin at a dose of at least 1500 mg/day in addition to their prescribed ACEI or ARB for hypertension. Patients will participate in the study for up to approximately 22 weeks.

Conditions

• Diabetes Mellitus, Type 2
• Plasma Volume

Interventions

Type	Name	Description
DRUG	Canagliflozin	Type = exact number, unit = mg, number = 300, form = capsule, route = oral use. One encapsulated tablet once daily for up to approximately 85 days (approximately 12 weeks)
DRUG	Placebo	Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-12-01
• Last updated: 2014-08-20

Locations

1 site across 1 country: Germany