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

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 - The CANTATA-M Trial / (CANagliflozin Treatment and Trial Analysis – Monotherapy)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015883-32-LT

Enrollment

450

Registered

2009-12-22

Start date

2010-02-18

Completion date

Unknown

Last updated

2012-10-09

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

Conditions

Type 2 Diabetes Mellitus MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: CANAGLIFLOZIN Product Code: JNJ-28431754 Pharmaceutical Form: Capsule INN or Proposed INN: CANAGLIFLOZIN Current Sponsor code: JNJ28431754 Other descriptive name: canagliflozin Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •All patients must have a diagnosis of T2DM •Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and 10% and =65 years) yes F.1.3.1 Number of subjects for this age range 135

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
Main Objective: Main Study: In subjects with T2DM who have inadequate glycemic control with diet and exercise: • To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. • To assess the safety and tolerability of canagliflozin. ;Primary end point(s): •To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) in the main study.;Secondary Objective: After 26 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: Fasting plasma glucose (FPG); Proportion of subjects with HbA1c <7% and <6.5%; Body weight; Postprandial plasma glucose concentrations; Systolic and diastolic blood pressure; Fasting plasma lipids; (Fasting measures of beta-cell function. After 52 weeks of treatment, to assess the effect of canagliflozin on: Glycemic control; Body weight; Proportion of subjects with HbA1c <7% and <6.5%; Systolic and diastolic blood pressure; Fasting plasma lipids. ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment with study drug.	—

Measure

Time frame

Main Objective: Main Study: In subjects with T2DM who have inadequate glycemic control with diet and exercise: • To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. • To assess the safety and tolerability of canagliflozin. ;Primary end point(s): •To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) in the main study.;Secondary Objective: After 26 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: Fasting plasma glucose (FPG); Proportion of subjects with HbA1c <7% and <6.5%; Body weight; Postprandial plasma glucose concentrations; Systolic and diastolic blood pressure; Fasting plasma lipids; (Fasting measures of beta-cell function. After 52 weeks of treatment, to assess the effect of canagliflozin on: Glycemic control; Body weight; Proportion of subjects with HbA1c <7% and <6.5%; Systolic and diastolic blood pressure; Fasting plasma lipids. ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment with study drug.

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Secondary

Measure	Time frame
Secondary end point(s): 1) To assess the effect of study drug on HbA1c. 2) To assess the effects of study drug on fasting plasma glucose (FPG) and body weight. 3) To assess the effect of study drug on postprandial plasma glucose concentrations. 4) To assess the effect of study drug on proportion of patients achieving an HbA1c <7%. 5) To assess effects of study drug on systolic and diastolic blood pressure and fasting plasma lipids.;Timepoint(s) of evaluation of this end point: 1) After 52 weeks of treatment in the main study 2) After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy) 3) After 26 weeks of treatment 4) After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy) 5) After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy)	—

Measure

Time frame

Secondary end point(s): 1) To assess the effect of study drug on HbA1c. 2) To assess the effects of study drug on fasting plasma glucose (FPG) and body weight. 3) To assess the effect of study drug on postprandial plasma glucose concentrations. 4) To assess the effect of study drug on proportion of patients achieving an HbA1c <7%. 5) To assess effects of study drug on systolic and diastolic blood pressure and fasting plasma lipids.;Timepoint(s) of evaluation of this end point: 1) After 52 weeks of treatment in the main study 2) After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy) 3) After 26 weeks of treatment 4) After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy) 5) After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy)

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Countries

Austria, Colombia, Estonia, Guatemala, Iceland, India, Korea, Republic of, Lithuania, Malaysia, Mexico, Philippines, Poland, Romania, South Africa, Spain, Sweden, United States

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com31(0)71524 21 66

Outcome results

None listed

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