Sitagliptin Cardiovascular Outcomes Study (MK-0431-082) | NCT00790205

ID	Type	Description	Link
2008_523	Other Identifier	Merck study number
2008-006719-20	EudraCT Number

Sitagliptin Cardiovascular Outcomes Study (MK-0431-082) | NCT00790205 | Trialant

Sponsor/Collaborators Module

Name	Class
Duke Clinical Research Institute, Oxford Diabetes Trials Unit	UNKNOWN

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sitagliptin	Experimental	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.	Drug: Sitagliptin
Placebo	Placebo Comparator	Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin	Drug	Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.	Sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)	Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.	Up to 5 years
Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)	Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.	Up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)	CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.	Up to 5 years
Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24268212	Result	Green JB, Bethel MA, Paul SK, Ring A, Kaufman KD, Shapiro DR, Califf RM, Holman RR. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. Am Heart J. 2013 Dec;166(6):983-989.e7. doi: 10.1016/j.ahj.2013.09.003. Epub 2013 Oct 23.
25600421

Arm/Group Information

ID	Title	Description
FG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
FG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0007332 subjects FG0017339 subjects
Treated		FG0007266 subjects FG0017274 subjects
COMPLETED		FG0006972 subjects FG0016905 subjects
NOT COMPLETED		FG000360 subjects FG001434 subjects

Type	Comment	Reasons
Lost to Follow-up		FG00061 subjects FG00171 subjects
Withdrawal by Subject		FG000299 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
BG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized	Age is unknown for 320 participants

Outcome Measures Module

Outcome Measures

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

Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)

Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.

Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001

Adverse Events Module

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	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Senior Vice President, Global Clinical Development	Merck Sharp & Dohme Corp.	1-800-672-6372		ClinicalTrialsDisclosure@merck.com

Condition Browse Module

ID	Term
D003924	Diabetes Mellitus, Type 2

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

Intervention Browse Module

ID	Term
D000068900	Sitagliptin Phosphate

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Title

Denominators

Categories

Adults 18 - 64 years

Title	Measurements
	BG0003315± 7.9 BG0013301± 8.0 BG00265.5± 8.0

From 65 - 84 years

Title	Measurements
	BG0003813 BG0013821 BG0027634

85 years and over

Title	Measurements
	BG00046 BG00155 BG002101

Unknown age

Title	Measurements
	BG000158 BG001162 BG002320

Estimated Glomerular Filtration Rate (eGFR)

Sitagliptin, n= 7254; Placebo, n= 7274; Total, n=14528

Mean

Standard Deviation

mL/min/1.73 m^2

Title

Denominators

Categories

Title	Measurements
	BG00074.9± 21.3 BG00174.9± 20.9 BG00274.9± 21.1

Hemoglobin A1c (HbA1c)

Sitagliptin, n= 7330; Placebo, n= 7336; Total, n= 14666

Mean

Standard Deviation

Percentage of HbA1c

Title

Denominators

Categories

Title	Measurements
	BG0007.2± 0.5 BG0017.2± 0.5 BG0027.2± 0.5

Urine albumin creatinine ratio

Sitagliptin, n= 2606; Placebo, n= 2542; Total, n= 5148

Mean

Standard Deviation

g/mol Creatinine

Title

Denominators

Categories

Title	Measurements
	BG0008.6± 37.4 BG0018.4± 36.0 BG0028.5± 36.7

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		Cox proportional hazards model	Model stratified by region with treatment group only as explanatory variable.	<0.001		Hazard Ratio (HR)	0.98			2-Sided	95	0.88	1.09					Non-Inferiority or Equivalence (legacy)	Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.

Primary

Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)

Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.

Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007332 OG0017339

Title

Denominators

Categories

Title	Measurements
	OG00011.4 OG00111.6

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		Cox proportional hazards model	Model stratified by region with treatment group only as explanatory variable.	<0.001		Hazard Ratio (HR)	0.98			2-Sided	95	0.89	1.08					Non-Inferiority or Equivalence (legacy)	Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.

Secondary

Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)

CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007257 OG0017266

Title

Denominators

Categories

Title	Measurements
	OG0008.4 OG0018.3

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		Cox proportional hazards model	Model stratified by region with treatment group only as explanatory variable.	<0.001		Hazard Ratio (HR)	0.99			2-Sided	95	0.89	1.11					Non-Inferiority or Equivalence (legacy)	Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.

Secondary

Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)

CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.

Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007332 OG0017339

Title

Denominators

Categories

Title	Measurements
	OG00010.2 OG00110.2

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		Cox proportional hazards model	Model stratified by region with treatment group only as explanatory variable.	<0.001		Hazard Ratio (HR)	0.99			2-Sided	95	0.89	1.10					Non-Inferiority or Equivalence (legacy)	Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.

Secondary

Percent Incidence of All-cause Mortality (Per Protocol Population)

Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007257 OG0017266

Title

Denominators

Categories

Title	Measurements
	OG0004.7 OG0014.3

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	Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.	Cox proportional hazards model		0.435		Hazard Ratio (HR)	1.06			2-Sided	95	0.91	1.24					Superiority or Other (legacy)

Secondary

Percent Incidence of All-cause Mortality (Intent to Treat Population)

Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.

Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007332 OG0017339

Title

Denominators

Categories

Title	Measurements
	OG0007.5 OG0017.3

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	Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.	Cox proportional hazards model		0.875		Hazard Ratio (HR)	1.01			2-Sided	95	0.90	1.14					Superiority or Other (legacy)

Secondary

Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)

Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007257 OG0017266

Title

Denominators

Categories

Title	Measurements
	OG0002.8(1.00 to 1.53) OG0012.8(0.84 to 1.33)

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	Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.	Cox proportional hazards model	Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.	0.858		Hazard Ratio (HR)	0.98			2-Sided	95	0.81	1.19					Superiority or Other (legacy)

Secondary

Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)

Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.

Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007332 OG0017339

Title

Denominators

Categories

Title	Measurements
	OG0003.1(1.00 to 1.53) OG0013.1(0.84 to 1.33)

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	Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.	Cox proportional hazards model	Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.	0.983		Hazard Ratio (HR)	1.00			2-Sided	95	0.83	1.20					Superiority or Other (legacy)

Secondary

Change From Baseline in Renal Function Over Time (Per Protocol Population)

Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method.

Posted

Mean

Standard Deviation

mL/min/1.73 m^2

Baseline and up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007182 OG0017203

Title

Denominators

Categories

Month 4; Sitagliptin, n= 3859; Placebo, n= 3864

Title	Measurements
	OG000-1.9± 14.2 OG001-0.8± 14.3

Month 8; Sitagliptin, n= 3562; Placebo, n= 3501

Title	Measurements
	OG000

Secondary

Change From Baseline in Renal Function Over Time (Intent to Treat Population)

Change in renal function based on eGFR using the MDRD method.

Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants with a baseline value.

Posted

Mean

Standard Deviation

mL/min/1.73 m^2

Baseline and up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007254 OG0017274

Title

Denominators

Categories

Month 4; Sitagliptin, n=3949; Placebo, n=3977

Title	Measurements
	OG000-1.8± 14.3 OG001-0.8± 14.3

Month 8; Sitagliptin, n=3687; Placebo, n=3648

Title	Measurements
	OG000

Secondary

Change From Baseline in HbA1c Over Time (Per Protocol Population)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Baseline and up to 4 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007250 OG0017258

Title

Denominators

Categories

Month 4; Sitagliptin, n=6632, Placebo, n=6588

Title	Measurements
	OG000-0.3± 0.8 OG0010.1± 0.9

Month 8; Sitagliptin, n=6294, Placebo, n=6197

Title	Measurements
	OG000

Secondary

Change From Baseline in HbA1c Over Time (Intent to Treat Population)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Baseline and up to 4 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007325 OG0017331

Title

Denominators

Categories

Month 4: Sitagliptin, n= 6772; Placebo, n= 6738

Title	Measurements
	OG000-0.3± 0.8 OG0010.1± 0.9

Month 8: Sitagliptin, n= 6478; Placebo, n= 6414

Title	Measurements
	OG000

Secondary

Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)

Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.

Posted

Mean

Standard Deviation

g/mol Creatinine

Baseline and up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0002590 OG0012522

Title

Denominators

Categories

Month 4; Sitagliptin, n=664; Placebo, n=688

Title	Measurements
	OG000-2.2± 27.7 OG001-1.4± 24.6

Month 8; Sitagliptin, n=635; Placebo, n=597

Title	Measurements
	OG000

Secondary

Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)

Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.

Posted

Mean

Standard Deviation

g/mol Creatinine

Baseline and up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0002606 OG0012542

Title

Denominators

Categories

Month 4; n=677, n=713

Title	Measurements
	OG000-2.1± 27.5 OG001-1.4± 24.1

Month 8; n=658, n=624

Title	Measurements
	OG000

Secondary

Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)

Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0005554 OG0015601

Title

Denominators

Categories

Title	Measurements
	OG0008.6 OG00111.9

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		Cox proportional hazards model	Model stratified by region with treatment group only as explanatory variable.	<0.001		Hazard Ratio (HR)	0.69			2-Sided	95	0.61	0.77					Superiority or Other (legacy)

Secondary

Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)

Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.

Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0005608 OG0015655

Title

Denominators

Categories

Title	Measurements
	OG0009.7 OG00113.2

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		Cox proportional hazards model	Model stratified by region with treatment group only as explanatory variable.	<0.001		Hazard Ratio (HR)	0.70			2-Sided	95	0.63	0.79					Superiority or Other (legacy)

Secondary

Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)

In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent [AHA] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007257 OG0017266

Title

Denominators

Categories

Title	Measurements
	OG00018.9 OG00124.5

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		Cox proportional hazards model	Model stratified by region with treatment group only as explanatory variable.	<0.001		Hazard Ratio (HR)	0.70			2-Sided	95	0.65	0.75					Superiority or Other (legacy)

Secondary

Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)

In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)

Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.

Posted

Number

Percentage of participants

Up to 5 years

ID	Title	Description
OG000	Sitagliptin	Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
OG001	Placebo	Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Units	Counts
Participants	OG0007332 OG0017339

Title

Denominators

Categories

Title	Measurements
	OG00021.7 OG00127.9

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		Cox proportional hazards model	Model stratified by region with treatment group only as explanatory variable.	<0.001		Hazard Ratio (HR)	0.72			2-Sided	95	0.68	0.77					Superiority or Other (legacy)