The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/006067

Enrollment

720

Registered

2011-01-04

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- Type 2 Diabetes Mellitus

Interventions

Intervention1: Canagliflozin: 300 mg Control Intervention1: Sitagliptin: 100 mg

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients between 18 and 65 years of age All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea Patients in the study must have a HbA1c between more than or equal to 7 and less than or equal to 10.5 percent and a fasting plasma glucose (FPG) less than 300 mg/dL (16.7 mmol/L)

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 or a severe hypoglycemic episode within 6 months before screening

Design outcomes

Primary

Measure	Time frame
The effect of canagliflozin compared with sitagliptin on hemoglobin A1c (HbA1c)Timepoint: After 52 weeks of treatment with study drug	—

Secondary

Measure	Time frame
The effect of canagliflozin compared with sitagliptin on body weightTimepoint: After 52 weeks of treatment with study drug;The effect of canagliflozin compared with sitagliptin on fasting plasma glucose (FPG)Timepoint: After 52 weeks of treatment with study drug;The effect of canagliflozin compared with sitagliptin on high-density lipoprotein cholesterol (HDL-C)Timepoint: After 52 weeks of treatment with study drug;The effect of canagliflozin compared with sitagliptin on systolic blood pressureTimepoint: After 52 weeks of treatment with study drug;The effect of canagliflozin compared with sitagliptin on triglyceridesTimepoint: After 52 weeks of treatment with study drug	—

Measure

Time frame

The effect of canagliflozin compared with sitagliptin on body weightTimepoint: After 52 weeks of treatment with study drug;The effect of canagliflozin compared with sitagliptin on fasting plasma glucose (FPG)Timepoint: After 52 weeks of treatment with study drug;The effect of canagliflozin compared with sitagliptin on high-density lipoprotein cholesterol (HDL-C)Timepoint: After 52 weeks of treatment with study drug;The effect of canagliflozin compared with sitagliptin on systolic blood pressureTimepoint: After 52 weeks of treatment with study drug;The effect of canagliflozin compared with sitagliptin on triglyceridesTimepoint: After 52 weeks of treatment with study drug

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Countries

Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, India, Israel, Malaysia, Netherlands, New Zealand, Other, Poland, Portugal, Republic of Korea, Singapore, Spain, Sweden, Ukraine

Contacts

Public ContactNafisa Fernandes

Johnson and Johnson Ltd.

TKorde@its.jnj.com9820208819

Outcome results

None listed

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