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The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Canagliflozin
Sitagliptin
Metformin immediate release
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 Type 2 diabetes mellitus, Canagliflozin, Placebo, Sitagliptin, Januvia, Metformin Immediate Release (IR), Hemoglobin A1c

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 IR
  • 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, 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 4

Arm Type

Experimental

Experimental

Active Comparator

Other

Arm Label

Canagliflozin 100 mg

Canagliflozin 300 mg

Sitagliptin 100 mg

Placebo/Sitagliptin

Arm Description

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

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

Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.

Each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin will be given with protocol-specified doses of metformin immediate release.

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 or sitagliptin 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 between each canagliflozin or sitagliptin group and placebo.
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 or sitagliptin group minus placebo) in the LS mean change.
Change in 2-hour Post-prandial Glucose From Baseline to Week 26
The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin 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 or sitagliptin 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 or sitagliptin 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 or sitagliptin 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 or sitagliptin group minus placebo) in the LS mean percent change.
Change in HbA1c From Baseline to Week 52
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Percent Change in Body Weight From Baseline to Week 52
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.
Change in Systolic Blood Pressure (SBP) From Baseline to Week 52
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Percent Change in Triglycerides From Baseline to Week 52
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.

Full Information

First Posted
April 1, 2010
Last Updated
July 25, 2013
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01106677
Brief Title
The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)
Official Title
A Randomized, Double-Blind, Placebo and Active-Controlled, 4-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 Monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
May 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 canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (i.e., treatment with a single drug) 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 nor the study doctor will know the identity of assigned study drug), placebo- and active-controlled, parallel-group, 4-arm (4 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) and an active-control (sitagliptin 100 mg, an antihyperglycemic agent) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin Immediate Release (IR) to control their diabetes. Approximately 1,260 patients with T2DM who are receiving treatment with metformin IR and have inadequate glycemic (blood sugar) will receive once-daily treatment with canagliflozin (100 mg or 300 mg), sitagliptin 100 mg, or placebo capsules for 26 weeks (Period I) followed by another 26-weeks where patients treated with canagliflozin (100 mg or 300 mg) or sitagliptin 100 mg will continue treatment for an additional 26 weeks and patients treated with placebo will be switched to active double-blind treatment with sitagliptin 100 mg capsules administered once-daily for 26 weeks (Period II). In addition, all patients will take protocol specified stable doses of metformin IR along with assigned study drug for the duration of the study. Patients will participate in the study for approximately 59 to 71 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, metformin IR, and reinforcement with diet and exercise, the patient will receive treatment with glimepiride (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 sign 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. Patients will take single-blind placebo for 2 weeks before randomization. After randomization, patients in the study will take double-blind canagliflozin (100 mg or 300 mg) or sitagliptin 100 mg for 52 weeks OR placebo for 26 weeks switched to double-blind treatment with sitaliptin 100 mg for 26 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
Type 2 diabetes mellitus, Canagliflozin, Placebo, Sitagliptin, Januvia, Metformin Immediate Release (IR), Hemoglobin A1c

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1284 (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 immediate release.
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 immediate release.
Arm Title
Sitagliptin 100 mg
Arm Type
Active Comparator
Arm Description
Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Arm Title
Placebo/Sitagliptin
Arm Type
Other
Arm Description
Each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin will be given with protocol-specified doses of metformin immediate release.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One matching placebo capsule orally (by mouth) once daily for 26 weeks with protocol-specified doses of metformin immediate release.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Intervention Description
One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.
Intervention Type
Drug
Intervention Name(s)
Metformin immediate release
Intervention Description
The patient's stable dose of metformin immediate release background 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 or sitagliptin 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 between each canagliflozin or sitagliptin group and placebo.
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 or sitagliptin group minus placebo) in the LS mean change.
Time Frame
Day 1 (Baseline) and Week 26
Title
Change in 2-hour Post-prandial Glucose From Baseline to Week 26
Description
The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin 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 or sitagliptin 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 or sitagliptin 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 or sitagliptin 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 or sitagliptin group minus placebo) in the LS mean percent change.
Time Frame
Day 1 (Baseline) and Week 26
Title
Change in HbA1c From Baseline to Week 52
Description
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Time Frame
Day 1 (Baseline) and Week 52
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Description
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Time Frame
Day 1 (Baseline) and Week 52
Title
Percent Change in Body Weight From Baseline to Week 52
Description
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.
Time Frame
Day 1 (Baseline) and Week 52
Title
Change in Systolic Blood Pressure (SBP) From Baseline to Week 52
Description
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.
Time Frame
Day 1 (Baseline) and Week 52
Title
Percent Change in Triglycerides From Baseline to Week 52
Description
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.
Time Frame
Day 1 (Baseline) and Week 52
Title
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52
Description
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.
Time Frame
Day 1 (Baseline) and Week 52

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 IR 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, 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 Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
Fountain Valley
State/Province
California
Country
United States
City
National City
State/Province
California
Country
United States
City
Northridge
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Brooksville
State/Province
Florida
Country
United States
City
Defuniak Springs
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Niceville
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Savannah
State/Province
Georgia
Country
United States
City
Champaign
State/Province
Illinois
Country
United States
City
Avon
State/Province
Indiana
Country
United States
City
Fishers
State/Province
Indiana
Country
United States
City
Franklin
State/Province
Indiana
Country
United States
City
West Des Moines
State/Province
Iowa
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Munfordville
State/Province
Kentucky
Country
United States
City
Portland
State/Province
Maine
Country
United States
City
Benzonia
State/Province
Michigan
Country
United States
City
Interlochen
State/Province
Michigan
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Picayune
State/Province
Mississippi
Country
United States
City
Florissant
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Mansfield
State/Province
New Jersey
Country
United States
City
New Hyde Park
State/Province
New York
Country
United States
City
Asheboro
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Oregon City
State/Province
Oregon
Country
United States
City
Altoona
State/Province
Pennsylvania
Country
United States
City
Tipton
State/Province
Pennsylvania
Country
United States
City
East Providence
State/Province
Rhode Island
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
New Braunfels
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Bountiful
State/Province
Utah
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Buenos Aires
Country
Argentina
City
Mendoza
Country
Argentina
City
San Juan
Country
Argentina
City
Pleven
Country
Bulgaria
City
Plovdiv
Country
Bulgaria
City
Sevlievo
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Barranquilla
Country
Colombia
City
Bogota
Country
Colombia
City
Medellin
Country
Colombia
City
Beroun
Country
Czech Republic
City
Pardubice
Country
Czech Republic
City
Plzen
Country
Czech Republic
City
Rychnov Nad Kneznou
Country
Czech Republic
City
Tabor
Country
Czech Republic
City
Tallinn
Country
Estonia
City
Piraeus
Country
Greece
City
Thessalonikis
Country
Greece
City
Ahmedabad, Gujarat
Country
India
City
Aurangabad
Country
India
City
Bangalore, Karnataka
Country
India
City
Bangalore
Country
India
City
Belgaum
Country
India
City
Coimbatore
Country
India
City
Mumbai
Country
India
City
Nagpur
Country
India
City
Pune
Country
India
City
Trivandrum
Country
India
City
Daugavpils
Country
Latvia
City
Limbazi
Country
Latvia
City
Riga
Country
Latvia
City
Talsi
Country
Latvia
City
Kelantan
Country
Malaysia
City
Kuala Lumpur N/A
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Pulau Pinang
Country
Malaysia
City
Selangor
Country
Malaysia
City
Culiacan
Country
Mexico
City
Guadalajara
Country
Mexico
City
Monterrey
Country
Mexico
City
Queretaro
Country
Mexico
City
Tampico
Country
Mexico
City
Lima 1 Lima Lima
Country
Peru
City
Leczyca
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Wroclaw
Country
Poland
City
Zgierz
Country
Poland
City
Aveiro
Country
Portugal
City
Leiria
Country
Portugal
City
Lisboa
Country
Portugal
City
Portalegre
Country
Portugal
City
San Juan
Country
Puerto Rico
City
Chelyabinsk
Country
Russian Federation
City
Dzerzhinsky Moscow Region
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Penza
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
St-Petersburg
Country
Russian Federation
City
Singapore
Country
Singapore
City
Banska Bystrica
Country
Slovakia
City
Bratislava
Country
Slovakia
City
Kosice
Country
Slovakia
City
Sahy
Country
Slovakia
City
Trebisov
Country
Slovakia
City
Göteborg
Country
Sweden
City
Stockholm
Country
Sweden
City
Bangkok
Country
Thailand
City
Chiang Mai
Country
Thailand
City
Khon Kaen
Country
Thailand
City
Ankara
Country
Turkey
City
Antalya
Country
Turkey
City
Istanbul
Country
Turkey
City
Izmir
Country
Turkey
City
Konya
Country
Turkey
City
Donetsk
Country
Ukraine
City
Ivano Frankivsk
Country
Ukraine
City
Kiev
Country
Ukraine
City
Sumy
Country
Ukraine
City
Vinnitsa
Country
Ukraine
City
Zaporozhye
Country
Ukraine

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
27391951
Citation
Schernthaner G, Lavalle-Gonzalez FJ, Davidson JA, Jodon H, Vijapurkar U, Qiu R, Canovatchel W. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):725-730. doi: 10.1080/00325481.2016.1210988. Epub 2016 Jul 26.
Results Reference
derived
PubMed Identifier
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The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

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