This is a study to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001337

Enrollment

240

Registered

2010-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetes Mellitus, Type 2 Renal Insufficiency

Interventions

Intervention1: Canagliflozin: 100 mg once daily for 52 weeks in addition to the patients AHA regimen used in accordance with local prescribing information Intervention2: Canagliflozin: 300 mg once dai

Eligibility

Inclusion criteria

Inclusion criteria: Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non oral agents) Patients with reduced kidney function

Exclusion criteria

Exclusion criteria: History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy Have proliferative diabetic retinopathy for which treatment is planned during the course of the study Kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen History of a severe hypoglycemic episode within 6 months before screening

Design outcomes

Primary

Measure	Time frame
To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) and to assess the safety and tolerability of canagliflozinTimepoint: The effect of canagliflozin will be assessed after 26 weeks of treatment with study drug. The safety and tolerability of canagliflozin will be assessed from time of signed informed consent to study end (includes up to 30 days following the last dose).	—

Measure

Time frame

To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) and to assess the safety and tolerability of canagliflozinTimepoint: The effect of canagliflozin will be assessed after 26 weeks of treatment with study drug. The safety and tolerability of canagliflozin will be assessed from time of signed informed consent to study end (includes up to 30 days following the last dose).

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Secondary

Measure	Time frame
To assess exposure-response relationships of canagliflozin using a population pharmacokinetic approach.Timepoint: Over 26 weeks of treatment;To assess the effects of canagliflozin relative to placebo on fasting plasma glucoseTimepoint: After 26 weeks of treatment;To assess the effects of canagliflozin relative to placebo on fasting plasma lipids, body weight, systolic and diastolic blood pressure, the proportion of patients achieving an HbA1c <7, and the proportion of patients receiving rescue therapy.Timepoint: After 26 and 52 weeks of treatment;To assess the effects of canagliflozin relative to placebo on glycemic control.Timepoint: After 52 weeks of treatment;To assess the effects of canagliflozin relative to placebo on renal functionTimepoint: After 26 and 52 weeks of treatment	—

Measure

Time frame

To assess exposure-response relationships of canagliflozin using a population pharmacokinetic approach.Timepoint: Over 26 weeks of treatment;To assess the effects of canagliflozin relative to placebo on fasting plasma glucoseTimepoint: After 26 weeks of treatment;To assess the effects of canagliflozin relative to placebo on fasting plasma lipids, body weight, systolic and diastolic blood pressure, the proportion of patients achieving an HbA1c <7, and the proportion of patients receiving rescue therapy.Timepoint: After 26 and 52 weeks of treatment;To assess the effects of canagliflozin relative to placebo on glycemic control.Timepoint: After 52 weeks of treatment;To assess the effects of canagliflozin relative to placebo on renal functionTimepoint: After 26 and 52 weeks of treatment

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Countries

Australia, Belgium, Brazil, Canada, France, Germany, Hong Kong, India, Italy, Latvia, Malaysia, Mexico, New Zealand, Poland, Republic of Korea, Romania, Russian Federation, South Africa, Spain, United States of America

Contacts

Public ContactDr Jitendra Dixit

jdixit@its.jnj.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026