The CANTATA-D2 Trial (CANagliflozin Treatment And Trial A... | NCT01137812

NCT01137812

ID	Type	Description	Link
28431754DIA3015	Other Identifier	Janssen Research & Development, LLC

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

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
Canagliflozin 300 mg	Experimental	Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea	Drug: Canagliflozin 300 mg Drug: Metformin Drug: Sulphonylurea
Sitagliptin 100 mg	Active Comparator	Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea	Drug: Sitagliptin 100 mg Drug: Metformin Drug: Sulphonylurea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin 100 mg	Drug	One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea	Sitagliptin 100 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.	Day 1 (Baseline) and Week 52

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients With HbA1c <7% at Week 52	The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage.	Week 52
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52

Eligibility Module

Contacts/Locations 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
29313267	Derived	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.
27977934	Derived

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
FG001	Sitagliptin 100 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
BG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
BG002	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
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.5± 9.62 BG00156.6± 9.33 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000170 BG001163 BG002

Region Treated

Number

participants

Title

Denominators

Categories

AUSTRIA

Title	Measurements
	BG0004 BG0012 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 52

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.

Posted

Least Squares Mean

Standard Error

Percent

Day 1 (Baseline) and Week 52

ID	Title	Description
OG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
OG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Units	Counts
Participants	OG000374 OG001365

Title

Denominators

Categories

Title	Measurements
	OG000-1.03± 0.048 OG001-0.66± 0.049

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	If the hypothesis of non-inferiority of canagliflozin to sitagliptin at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference [canagliflozin minus sitagliptin] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to sitagliptin would be concluded.	ANCOVA		<0.05		Least-Squares Mean Difference	-0.37	Standard Error of the Mean	0.064	2-Sided	95	-0.500	-0.250				Yes	Non-Inferiority or Equivalence	Power calculation: assuming a difference between canagliflozin and sitagliptin of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.025, it was estimated that 234 patients per group would provide approximately 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with sitagliptin.

Secondary

Percentage of Patients With HbA1c <7% at Week 52

The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage.

Posted

Number

Percentage of patients

Week 52

ID	Title	Description
OG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
OG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Units	Counts
Participants

Secondary

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 treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

Posted

Least Squares Mean

Standard Error

mg/dL

Day 1 (Baseline) and Week 52

ID	Title	Description
OG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
OG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Units	Counts
Participants

Secondary

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 treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 52

ID	Title	Description
OG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
OG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Units	Counts
Participants

Secondary

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 treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

Posted

Least Squares Mean

Standard Error

mmHg

Day 1 (Baseline) and Week 52

ID	Title	Description
OG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
OG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Units	Counts
Participants

Secondary

Percent Change in Triglycerides From Baseline to Week 52

The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 52

ID	Title	Description
OG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
OG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Units	Counts
Participants

Secondary

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52

The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

Posted

Least Squares Mean

Standard Error

Percent change

Day 1 (Baseline) and Week 52

ID	Title	Description
OG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
OG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Canagliflozin 300 mg	Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.			24	377	157	377
EG001	Sitagliptin 100 mg	Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.			21	378	159	378

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Cardiac arrest	Cardiac disorders	MEDDRA 14.1	Non-systematic Assessment	EG0002 affected377 at risk EG0010 affected378 at risk
Coronary artery disease	Cardiac disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Myocardial infarction	Cardiac disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0012 affected378 at risk
Pancreatitis	Gastrointestinal disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Small intestinal obstruction	Gastrointestinal disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Bile duct obstruction	Hepatobiliary disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Cholelithiasis	Hepatobiliary disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Gallbladder oedema	Hepatobiliary disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Bronchopneumonia	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Leptospirosis	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Pneumonia	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0012 affected378 at risk
Pneumonia bacterial	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Pyelonephritis chronic	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Arthropod bite	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Contusion	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Hand fracture	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Hip fracture	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Incisional hernia, obstructive	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Splenic rupture	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Tendon rupture	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Wound	Injury, poisoning and procedural complications	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Obesity	Metabolism and nutrition disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Oropharyngeal cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Cerebrovascular accident	Nervous system disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Cervical cord compression	Nervous system disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Convulsion	Nervous system disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Transient ischaemic attack	Nervous system disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk
Suicide attempt	Psychiatric disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Renal colic	Renal and urinary disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MEDDRA 14.1	Non-systematic Assessment	EG0002 affected377 at risk EG0010 affected378 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Arterial thrombosis limb	Vascular disorders	MEDDRA 14.1	Non-systematic Assessment	EG0001 affected377 at risk EG0010 affected378 at risk
Arteriosclerosis	Vascular disorders	MEDDRA 14.1	Non-systematic Assessment	EG0000 affected377 at risk EG0011 affected378 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MEDDRA 14.1	Non-systematic Assessment	EG00017 affected377 at risk EG00126 affected378 at risk
Influenza	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG00022 affected377 at risk EG00115 affected378 at risk
Nasopharyngitis	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG00033 affected377 at risk EG00138 affected378 at risk
Upper respiratory tract infection	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG00033 affected377 at risk EG00121 affected378 at risk
Urinary tract infection	Infections and infestations	MEDDRA 14.1	Non-systematic Assessment	EG00015 affected377 at risk EG00119 affected378 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MEDDRA 14.1	Non-systematic Assessment	EG00066 affected377 at risk EG00175 affected378 at risk
Headache	Nervous system disorders	MEDDRA 14.1	Non-systematic Assessment	EG00029 affected377 at risk EG00127 affected378 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
D000068900	Sitagliptin Phosphate
D000068896	Canagliflozin
D008687	Metformin
D013453	Sulfonylurea Compounds

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D014508	Urea
D000577	Amides
D013450	Sulfones

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama		United States

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