The CANTATA-MSU Trial (CANagliflozin Treatment and Trial Analysis – Metformin and SUlphonylurea)

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

Conditions

• Type 2 diabetes mellitus

Study Type

Interventional

Study Design

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c).
  [ Time Frame: After 26 weeks of treatment with study drug. ]
  [ Designated as safety issue: No ]

Secondary Outcome Measures:

• To assess the effect of study drug on fasting plasma glucose (FPG), fasting plasma lipids, and fasting measure of beta-cell function [ Time Frame: After 26 and 52 weeks of treatment ]
  [ Designated as safety issue: No ]
• To assess the effect of study drug on the proportion of patients achieving an HbA1c <7 and <6.5%
  [ Time Frame: After 26 and 52 weeks of treatment ]
  [ Designated as safety issue: No ]
• To assess the effect of study drug on systolic and diastolic blood pressure and body weight
  [ Time Frame: After 26 and 52 weeks of treatment ]
  [ Designated as safety issue: No ]
• To assess the effect of study drug on time to rescue therapy and proportion of patients receiving rescue therapy
  [ Time Frame: After 26 and 52 weeks of treatment ]
  [ Designated as safety issue: No ]
• To assess the effect of study drug on HbA1c
  [ Time Frame: After 52 weeks of treatment ]
  [ Designated as safety issue: No ]

 

Arms and Assigned Interventions

Arms	Assigned Interventions
001: Experimental  Canagliflozin 100 mg 100 mg capsule once daily for 52 weeks with protocol-specified  doses of metformin and sulphonylurea.	Drug: Canagliflozin 100 mg 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
002: Experimental Canagliflozin 300 mg 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.	Drug: Canagliflozin 300 mg 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
003: Placebo Comparator Placebo 1 placebo capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.	Drug: Placebo 1 placebo capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Study Start

March 2010-January 2012

Eligibility & Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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 >=7 and <=10.5%
• Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

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

Total Enrolment

450

Contact Details

Email: info1@veritasmedicine.com

Australia

• Fremantle, Western Australia 
• Heidelberg Heights, Victoria
• Meadowbrook, Queensland
• Nedlands, Western Australia
• Wollongong, New South Wales