The CANTATA-MP Trial (CANagliflozin Treatment and Trial A... | NCT01106690

ID	Type	Description	Link
28431754DIA3012	Other Identifier	Janssen Research & Development, LLC

Status Module

Oversight Module

Description Module

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), 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 pioglitazone to control their diabetes. Approximately 360 patients with T2DM who are receiving combination therapy with metformin and pioglitazone will receive the addition of once-daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 26 weeks followed by a 26-week extension period where patients treated with canagliflozin (100 mg or 300 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, an antihyperglycemic agent administered once-daily for 26 weeks. In addition, all patients will take protocol specified stable doses of metformin and pioglitazone along with assigned study drug for the duration of the study. Patients will participate in the study for approximately 59 to 78 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with glimepiride (rescue therapy) in accordance 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 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 capsules for 2 weeks before randomization. After randomization, patients will take double-blind canagliflozin (100 mg or 300 mg) for 52 weeks OR placebo for 26 weeks switched to double-blind sitagliptin 100 mg for 26 weeks.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo/Sitagliptin	Other	Each patient will receive matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients will be switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Drug: Placebo Drug: Sitagliptin Drug: Metformin Drug: Pioglitazone
Canagliflozin 100 mg	Experimental	Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Drug: Canagliflozin Drug: Metformin Drug: Pioglitazone
Canagliflozin 300 mg	Experimental	Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Drug: Canagliflozin Drug: Metformin Drug: Pioglitazone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.	Placebo/Sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Day 1 (Baseline) and Week 26

Secondary Outcomes

Measure	Description	Time Frame
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.	Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

Eligibility Module

Name	Affiliation	Role
Janssen Research & Development, LLC C. Clinical Trial	Janssen Research & Development, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28327140	Derived	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.
28241822	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
BG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
BG002	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.3± 9.56 BG00156.7± 10.36 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039 BG00136 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

CANADA

Title	Measurements
	BG00024 BG00122 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

Posted

Least Squares Mean

Standard Error

Percent

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
OG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
OG002	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.

Units	Counts
Participants	OG000114 OG001113 OG002112

Title

Denominators

Categories

Title	Measurements
	OG000-0.26± 0.069 OG001-0.89± 0.069 OG002-1.03± 0.070

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.001		Least-Squares Mean Difference	-0.62	Standard Error of the Mean	0.095	2-Sided	95	-0.811	-0.437				No	Superiority or Other
OG000 OG002		ANCOVA		<0.001

Secondary

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.

Posted

Number

Percentage of patients

Week 26

ID	Title	Description
OG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
OG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
OG002	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.

Secondary

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.

Posted

Least Squares Mean

Standard Error

mg/dL

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
OG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
OG002	Canagliflozin 300 mg

Secondary

Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26

HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B 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.

Posted

Least Squares Mean

Standard Error

HOMA2-%B

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
OG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
OG002

Secondary

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.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
OG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
OG002	Canagliflozin 300 mg

Secondary

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.

Posted

Least Squares Mean

Standard Error

mmHg

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
OG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
OG002	Canagliflozin 300 mg

Secondary

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.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
OG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
OG002	Canagliflozin 300 mg

Secondary

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.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 26

ID	Title	Description
OG000	Placebo/Sitagliptin	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
OG001	Canagliflozin 100 mg	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
OG002	Canagliflozin 300 mg

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo/Sitagliptin: Baseline to Week 26	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 26.	5	115	31	115
EG001	Canagliflozin 100 mg: Baseline to Week 26	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.	3	113	35	113
EG002	Canagliflozin 300 mg: Baseline to Week 26	Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.	4	114	40	114
EG003	Placebo/Sitagliptin: Baseline to Week 52	Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 52.	6	115	49	115
EG004	Canagliflozin 100 mg: Baseline to Week 52	Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.	8	113	48	113
EG005	Canagliflozin 300 mg: Baseline to Week 52	Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.	7	114	57	114

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute coronary syndrome	Cardiac disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG0031 affected115 at risk EG004
Dyspepsia	Gastrointestinal disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Chest pain	General disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0011 affected113 at risk EG0020 affected114 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0011 affected113 at risk EG0020 affected114 at risk EG003
Anal abscess	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0011 affected113 at risk EG0020 affected114 at risk EG003
Escherichia bacteraemia	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Gastrointestinal infection	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Osteomyelitis	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0021 affected114 at risk EG003
Sepsis syndrome	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Concussion	Injury, poisoning and procedural complications	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0021 affected114 at risk EG003
Laceration	Injury, poisoning and procedural complications	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0021 affected114 at risk EG003
Periprosthetic fracture	Injury, poisoning and procedural complications	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0011 affected113 at risk EG0020 affected114 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0021 affected114 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0021 affected114 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52.	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Hypotension	Vascular disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Bacterial Sepsis	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Bronchopneumonia	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Cellulitis	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Arteriogram coronary	Investigations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Pelvic prolapse	Reproductive system and breast disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Cerebrovascular accident	Nervous system disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003
Dizziness postural	Nervous system disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0010 affected113 at risk EG0020 affected114 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Diarrhoea	Gastrointestinal disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0006 affected115 at risk EG0014 affected113 at risk EG0024 affected114 at risk EG0037 affected115 at risk EG004
Nasopharyngitis	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0006 affected115 at risk EG0016 affected113 at risk EG00211 affected114 at risk EG003
Upper respiratory tract infection	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0007 affected115 at risk EG0019 affected113 at risk EG0025 affected114 at risk EG003
Urinary tract infection	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0006 affected115 at risk EG0014 affected113 at risk EG0024 affected114 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0000 affected115 at risk EG0013 affected113 at risk EG0026 affected114 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52. In the Week 26 study report, 2 patients had hypoglycaemia recorded in error by the investigator, which were corrected in the Week 52 study report.	EG0002 affected115 at risk EG0011 affected113 at risk EG0026 affected114 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0002 affected115 at risk EG0011 affected113 at risk EG0026 affected114 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0003 affected115 at risk EG0018 affected113 at risk EG0025 affected114 at risk EG003
Pollakiuria	Renal and urinary disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0001 affected115 at risk EG0015 affected113 at risk EG0027 affected114 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52	EG0006 affected115 at risk EG0013 affected113 at risk EG0021 affected114 at risk EG003
Oedema peripheral	General disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52.	EG0002 affected115 at risk EG0012 affected113 at risk EG0024 affected114 at risk EG003
Headache	Nervous system disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52.	EG0004 affected115 at risk EG0013 affected113 at risk EG0025 affected114 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MEDDRA 14.1 / 15.0	Non-systematic Assessment	MEDDRA 14.1 used for Week 26/MEDDRA 15.0 for Week 52.	EG0003 affected115 at risk EG0011 affected113 at risk EG0023 affected114 at risk EG003

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D014230	Triazoles
D001393	Azoles
D011719	Pyrazines
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D045162	Thiazolidinediones
D013844	Thiazoles

Facility	Status	City	State	ZIP	Country	Contacts
		Anniston	Alabama		United States

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D000068896	Canagliflozin
D000068900	Sitagliptin Phosphate
D008687	Metformin
D000077205	Pioglitazone