This study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002824

Enrollment

450

Registered

2010-10-26

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

Interventions

Intervention1: Canagliflozin 300 mg 300 mg capsule once daily for 26 weeks in patients in the High Glycemic Cohort Substudy: 300 mg capsule once daily for 26 weeks in patients in the High Glycemic Coh

Eligibility

Inclusion criteria

Inclusion criteria: All patients must have a diagnosis of T2DM Patients in the main study must have a Hemoglobin A1c HbA1c between less than or equal to 7percent and more than or equal to 10percent and a fasting plasma glucose FPG less than 270 mgperdL 15 mmolperL Patients in the High Glycemic Cohort Substudy must have an HbA1c between 10percent and 12percent and a FPG less than or equal to 50 mgperdL 19.44 mmolperL

Exclusion criteria

Exclusion criteria: History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or 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) in the main study.Timepoint: After 26 weeks of treatment with study drug	—

Secondary

Measure	Time frame
To assess effects of study drug on systolic and diastolic blood pressure and fasting plasma lipids.Timepoint: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy);To assess the effect of study drug on HbA1cTimepoint: After 52 weeks of treatment in the main study;To assess the effect of study drug on postprandial plasma glucose concentrationsTimepoint: After 26 weeks of treatment;To assess the effect of study drug on proportion of patients achieving an HbA1c <7%Timepoint: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy);To assess the effects of study drug on fasting plasma glucose (FPG) and body weightTimepoint: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy)	—

Measure

Time frame

To assess effects of study drug on systolic and diastolic blood pressure and fasting plasma lipids.Timepoint: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy);To assess the effect of study drug on HbA1cTimepoint: After 52 weeks of treatment in the main study;To assess the effect of study drug on postprandial plasma glucose concentrationsTimepoint: After 26 weeks of treatment;To assess the effect of study drug on proportion of patients achieving an HbA1c <7%Timepoint: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy);To assess the effects of study drug on fasting plasma glucose (FPG) and body weightTimepoint: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy)

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Countries

India

Contacts

Public ContactHarsha Kadri

JDixit@its.jnj.com022--25715556

Outcome results

None listed

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