Status:
COMPLETED
A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Diabetes Mellitus, Type 2
Plasma Volume
Eligibility:
All Genders
25-70 years
Phase:
PHASE1
Brief 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 treate...
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)...
Eligibility Criteria
Inclusion
- All patients must have a diagnosis of T2DM with inadequate glycemic control (ie, HbA1c of \>=7.0% and \<=9.0% at Screening) on metformin monotherapy and be receiving therapy with an antihypertensive agent (an ACEI or ARB) for at least 4 weeks prior to Screening
Exclusion
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; or a severe hypoglycemic episode within 6 months before screening
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01483781
Start Date
December 1 2011
End Date
August 1 2012
Last Update
August 20 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Neuss, Germany