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

NCT01483781 | Completed Phase 1 DMC

• 3 other identifiers: CR10068528431754DIA10472011-004117-17
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 treated for high blood pressure.

Conditions

Diabetes Mellitus, Type 2; Plasma Volume

Keywords

Diabetes Mellitus, Type 2; Plasma Volume; Canagliflozin; Metformin; Hemoglobin A1c; Hypertension; Angiotensin-Converting Enzyme Inhibitors (ACEIs); Angiotensin Receptor Blockers (ARBs); Pharmacodynamics; Pharmacokinetics

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• Number of hypoglycemic events reported

  Baseline is defined as up to 3 days predose (Week -1)

  Baseline up to Day 98

• Change in electrocardiogram (ECG) parameters

  Baseline is defined as up to 3 days predose (Week -1)

  Baseline up to Day 98

• Change in blood pressure measurements

  Baseline is defined as up to 3 days predose (Week -1)

  Baseline up to Day 98

• 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

• Change from baseline in pulse rate (beats/minute)

  Baseline is defined as up to 3 days predose (Week -1)

  Baseline up to Day 98

• Change in chemistry laboratory analytes

  Baseline is defined as up to 3 days predose (Week -1)

  Baseline up to Day 98

• Change from baseline in urinalysis laboratory analytes

  Baseline is defined as up to 3 days predose (Week -1)

  Baseline up to Day 98

• Change in hematology laboratory analytes

  Baseline is defined as up to 3 days predose (Week -1)

  Baseline up to Day 98

Secondary Outcomes (6)

• Change in PV

  Baseline to Week 1 of the double-blind treatment period

• Change in body weight

  Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase

• Change in 24-hour urine volume

  Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase

• Change in 24-hour fractional and total excretion of uric acid

  Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase

• Change in urine pH

  Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase

Study Arms (2)

Canagliflozin

EXPERIMENTAL

Drug: Canagliflozin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Canagliflozin DRUG

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)

Canagliflozin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Neuss, Germany

Location

Related 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Janssen Research & Development, LLC L.L.C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 1, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

DE (1)