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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483781
• Other study ID #: CR100685
• Secondary ID: 28431754DIA10472
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2011
• Last updated: August 19, 2014
• Start date: December 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitute fur Arzneimittel and Medizinproduckte (Federal Institute for Medicinal products and Devices)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

-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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Plasma Volume

Intervention

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)
• Placebo
Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma volume (PV)	Baseline is defined as up to 3 days predose (Week -1)	Baseline to Week 12 of the double-blind treatment period	No
Primary	Number of patients who experience at least 1 occurrence of a treatment-related adverse event	Treatment-related adverse events are adverse events with onset during the treatment phase.	Day 1 to Day 85	No
Primary	Number of hypoglycemic events reported	Baseline is defined as up to 3 days predose (Week -1)	Baseline up to Day 98	No
Primary	Change in electrocardiogram (ECG) parameters	Baseline is defined as up to 3 days predose (Week -1)	Baseline up to Day 98	No
Primary	Change in blood pressure measurements	Baseline is defined as up to 3 days predose (Week -1)	Baseline up to Day 98	No
Primary	Number of patients with physical examination findings reported as adverse events	Baseline is defined as up to 3 days predose (Week -1)	Baseline up to Week 12	No
Primary	Change from baseline in pulse rate (beats/minute)	Baseline is defined as up to 3 days predose (Week -1)	Baseline up to Day 98	No
Primary	Change in chemistry laboratory analytes	Baseline is defined as up to 3 days predose (Week -1)	Baseline up to Day 98	No
Primary	Change from baseline in urinalysis laboratory analytes	Baseline is defined as up to 3 days predose (Week -1)	Baseline up to Day 98	No
Primary	Change in hematology laboratory analytes	Baseline is defined as up to 3 days predose (Week -1)	Baseline up to Day 98	No
Secondary	Change in PV	Baseline is defined as up to 3 days predose (Week -1)	Baseline to Week 1 of the double-blind treatment period	No
Secondary	Change in body weight	Baseline is defined as up to 3 days predose (Week -1)	Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase	No
Secondary	Change in 24-hour urine volume	Baseline is defined as up to 3 days predose (Week -1)	Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase	No
Secondary	Change in 24-hour fractional and total excretion of uric acid	Baseline is defined as up to 3 days predose (Week -1)	Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase	No
Secondary	Change in urine pH	Baseline is defined as up to 3 days predose (Week -1)	Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase	No
Secondary	Change in percent Hemoglobin A1c (HbA1c)	Baseline is defined as up to 3 days predose (Week -1)	Baseline to Week 12	No

External Links

•   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