CompletedPhase 3ACTRN12610000194066

A Randomised Double-Blind Placebo-Controlled Multicenter Study with Extension to Evaluate the Efficacy Safety and Tolerability of Canagliflozin in the Treatment of Subjects with Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

A Randomised Double-Blind Placebo-Controlled Multicenter Study with Extension to Evaluate the Efficacy Safety and Tolerability of Canagliflozin in the Treatment of Subjects with Type 2 Diabetes Mellitus Who Have Moderate Renal


Sponsor

Johnson& Johnson Pharmaceutical Research & Development, LLC

Enrollment

240 participants

Start Date

Jun 7, 2010

Study Type

Interventional

Conditions

Summary

The study aims to compare 2 doses of canagliflozin against placebo in treating patients over 25 years of age, who have inadequately controlled type 2 diabetes and moderate renal impairment. Patients will be randomised to receive either 100mg or 300mg of canagliflozin or placebo for 26 weeks, in addition to their current diabetes medication, with a possibility of continuing for an additional 26 weeks. The study is blinded so neither the patients nor the site staff will know what the patient is taking and there is an equal change of receiving the different doses of canagliflozin or placebo. The study will asses patients for how well their diabetes is controlled on the study and also assess any side effects they have whilst taking study medication. In order to achieve this patients will have to attend regular clinic visits intially every 3 weeks then 6 - 8 weekly for first 26 weeks. In the second 26 weeks there are only 2 visits 18 weeks apart. During these visits blood samples will be taken and analaysed and patients will be asked how they feel and this will all be recorded on a case report form. Patients will also be asked to complete a diary during the study, recording their blood sugar levels (taken on a monitor provided by the sponsor), any problems they have between visits and when they take their study medication.


Eligibility

Sex: Both males and femalesMin Age: 25 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a new diabetes medication called canagliflozin in people with type 2 diabetes who also have moderately reduced kidney function. It is for adults aged 25 and older with type 2 diabetes and moderate kidney impairment whose blood sugar is not well controlled.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Canagliflozin (JNJ-28431754) oral capsule, daily dose either 100mg or 300mg. Dose will be assigned randomly. Canagliflozin against placebo in treating patients over 25 years of age, who have inadeq

Canagliflozin (JNJ-28431754) oral capsule, daily dose either 100mg or 300mg. Dose will be assigned randomly. Canagliflozin against placebo in treating patients over 25 years of age, who have inadequately controlled type 2 diabetes and moderate renal impairment. Patients will be randomised to receive either 100mg or 300mg of canagliflozin or placebo for 26 weeks, in addition to their current diabetes medication, with an extension of 26 weeks.Total treatment phase is 52 weeks. Study drug and placebo will be tablet form and taken orally.


Locations(15)

New Zealand

India

Korea, Democratic People's Republic Of

Belgium

France

Germany

Italy

Latvia

Romania

Russian Federation

Spain

Brazil

Mexico

Canada

United States of America

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ACTRN12610000194066