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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Canagliflozin
Placebo
Metformin
Sulphonylruea
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Canagliflozin, Placebo, Metformin, Sulphonylurea, Hemoglobin A1c, Type 2 diabetes mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Canagliflozin 100 mg

Canagliflozin 300 mg

Placebo

Arm Description

Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Each patient will receive matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Secondary Outcome Measures

Percentage of Patients With HbA1c <7% at Week 26
The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Percent Change in Body Weight From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Percent Change in Triglycerides From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

Full Information

First Posted
April 1, 2010
Last Updated
June 12, 2013
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01106625
Brief Title
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), placebo-controlled, parallel-group, 3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes. Approximately 450 patients with T2DM who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control will receive once daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 52 weeks (includes 26 weeks of double-blind treatment followed by a 26-week extension period). In addition, all patients will take protocol-specified stable doses of metformin and sulphonylurea for the duration of the study. Patients will participate in the study for approximately 59 to 72 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with insulin (rescue therapy) consistent with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is to assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. All patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double-blind canagliflozin (100 mg or 300 mg) or matching placebo for 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Canagliflozin, Placebo, Metformin, Sulphonylurea, Hemoglobin A1c, Type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
469 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin 100 mg
Arm Type
Experimental
Arm Description
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Arm Title
Canagliflozin 300 mg
Arm Type
Experimental
Arm Description
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each patient will receive matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Intervention Description
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
The patient's stable dose of background metformin therapy should be continued throughout the study.
Intervention Type
Drug
Intervention Name(s)
Sulphonylruea
Intervention Description
The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Week 26
Description
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Time Frame
Day 1 (Baseline) and Week 26
Secondary Outcome Measure Information:
Title
Percentage of Patients With HbA1c <7% at Week 26
Description
The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Time Frame
Week 26
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Description
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in Body Weight From Baseline to Week 26
Description
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Time Frame
Day 1 (Baseline) and Week 26
Title
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Description
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in Triglycerides From Baseline to Week 26
Description
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Description
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Time Frame
Day 1 (Baseline) and Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC C. Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Little Rock
State/Province
Alaska
Country
United States
City
Phoenix
State/Province
Arizona
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United States
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Chino
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California
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United States
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Fair Oaks
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California
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United States
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Roseville
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California
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United States
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Wes Hills
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California
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United States
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Waterbury
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Connecticut
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Jacksonville
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Florida
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New Port Richey
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Florida
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Ocala
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St Petersburg
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Florida
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West Palm Beach
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Florida
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Augusta
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Georgia
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Roswell
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Georgia
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Chicago
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Illinois
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Lexington
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Kentucky
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New Orleans
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Louisiana
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Reisterstown
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Maryland
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Olive Branch
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Mississippi
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Saint Louis
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Missouri
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United States
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Westfield
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New York
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Greenville
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North Carolina
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Cincinnati
State/Province
Ohio
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Tulsa
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Oklahoma
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Medford
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Oregon
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Altoona
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Pennsylvania
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United States
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Harleysville
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Pennsylvania
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Levittown
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Pennsylvania
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Sellersville
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Pennsylvania
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Greer
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South Carolina
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United States
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Bryan
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Texas
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Dallas
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Texas
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United States
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Desoto
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Texas
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United States
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Salt Lake City
State/Province
Utah
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United States
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South Burlington
State/Province
Vermont
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United States
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Wenatchee
State/Province
Washington
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United States
City
Freemantle
Country
Australia
City
Heidelberg Heights
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Australia
City
Meadowbrook
Country
Australia
City
Nedlands
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Australia
City
Wollongong
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Australia
City
Aalst
Country
Belgium
City
Bonheiden
Country
Belgium
City
Edegem
Country
Belgium
City
Leuven
Country
Belgium
City
Corbeil Essonnes
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France
City
La Rochelle
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France
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Le Creusot
Country
France
City
Poitiers
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France
City
Venissieux
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France
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Guatemala
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Guatemala
City
Balatonfured
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Hungary
City
Budapest
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Hungary
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Győr
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Hungary
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Zalaegerszeg
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Hungary
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Tel Aviv
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Israel
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Guadalajara
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Mexico
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Monterrey
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Mexico
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Carolina
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Puerto Rico
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Trujillo Alto
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Puerto Rico
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Arkhangelsk
Country
Russian Federation
City
Saint Petersburg
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Russian Federation
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Samara
Country
Russian Federation
City
Alicante
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Spain
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Almeria
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Belfast
Country
United Kingdom
City
Bolton
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29313267
Citation
Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.
Results Reference
derived
PubMed Identifier
28327140
Citation
Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.
Results Reference
derived
PubMed Identifier
28241822
Citation
Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.
Results Reference
derived
PubMed Identifier
28197834
Citation
Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.
Results Reference
derived
PubMed Identifier
27977934
Citation
Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.
Results Reference
derived
PubMed Identifier
27600862
Citation
John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.
Results Reference
derived
PubMed Identifier
26580237
Citation
Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.
Results Reference
derived
PubMed Identifier
26579834
Citation
Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.
Results Reference
derived
PubMed Identifier
26373629
Citation
Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.
Results Reference
derived
PubMed Identifier
26121561
Citation
Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.
Results Reference
derived
PubMed Identifier
25813214
Citation
Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.
Results Reference
derived
PubMed Identifier
25329038
Citation
Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.
Results Reference
derived
PubMed Identifier
24918789
Citation
Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.
Results Reference
derived
PubMed Identifier
24786834
Citation
Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.
Results Reference
derived
PubMed Identifier
24742013
Citation
Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.
Results Reference
derived
PubMed Identifier
24585202
Citation
Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.
Results Reference
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PubMed Identifier
24517339
Citation
Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.
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The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

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