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Completed

NCT Number: NCT01483781

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Plasma Volume Vascular Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Placebo

Drug

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

Primary outcomes

  1. Change in plasma volume (PV)

    Time frame: Baseline to Week 12 of the double-blind treatment period

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

  2. Number of patients who experience at least 1 occurrence of a treatment-related adverse event

    Time frame: Day 1 to Day 85

    Treatment-related adverse events are adverse events with onset during the treatment phase.

  3. Number of hypoglycemic events reported

    Time frame: Baseline up to Day 98

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

  4. Change in electrocardiogram (ECG) parameters

    Time frame: Baseline up to Day 98

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

  5. Change in blood pressure measurements

    Time frame: Baseline up to Day 98

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

  6. Number of patients with physical examination findings reported as adverse events

    Time frame: Baseline up to Week 12

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

  7. Change from baseline in pulse rate (beats/minute)

    Time frame: Baseline up to Day 98

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

  8. Change in chemistry laboratory analytes

    Time frame: Baseline up to Day 98

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

  9. Change from baseline in urinalysis laboratory analytes

    Time frame: Baseline up to Day 98

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

  10. Change in hematology laboratory analytes

    Time frame: Baseline up to Day 98

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

Secondary outcomes

  1. Change in PV

    Time frame: Baseline to Week 1 of the double-blind treatment period

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

  2. Change in body weight

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

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

  3. Change in 24-hour urine volume

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

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

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

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

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

  5. Change in urine pH

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

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

  6. Change in percent Hemoglobin A1c (HbA1c)

    Time frame: Baseline to Week 12

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

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2011
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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