Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT01076088

First received: February 24, 2010

Last updated: April 27, 2017

Last verified: April 2017

History of Changes

Results First Received: December 17, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Investigator; Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: Sitagliptin 50 mg Drug: Metformin 500 mg Drug: Sitagliptin 100 mg Drug: Placebo Drug: Metformin 850 mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 744 participants were randomized to treatment. Of these 744 participants, 1 participant, assigned to the placebo group, did not receive study medication. This participant was not included in the safety analyses.

Reporting Groups

	Description
Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
Sitagliptin 50 mg + Metformin 850 mg	Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
Metformin 500 mg	Metformin 500 mg twice daily
Metformin 850	Metformin 850 mg twice daily
Sitagliptin 100 mg	Sitagliptin 100 mg once daily
Placebo	Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.

Participant Flow: Overall Study

	Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg + Metformin 850 mg	Metformin 500 mg	Metformin 850	Sitagliptin 100 mg	Placebo
STARTED	122	125	126	124	120	127
COMPLETED	111	107	109	109	104	104
NOT COMPLETED	11	18	17	15	16	23
Adverse Event	1	6	3	2	3	3
Lost to Follow-up	1	1	0	1	1	2
Non-compliance with study drug	0	0	0	1	0	0
Physician Decision	1	3	0	1	1	0
Withdrawal by Subject	8	8	14	10	11	17
Other protocol specified criteria	0	0	0	0	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
Sitagliptin 50 mg + Metformin 850 mg	Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
Metformin 500 mg	Metformin 500 mg twice daily
Metformin 850	Metformin 850 mg twice daily
Sitagliptin 100 mg	Sitagliptin 100 mg once daily
Placebo	Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
Total	Total of all reporting groups

Baseline Measures

Sitagliptin 50 mg + Metformin 500 mg

Sitagliptin 50 mg + Metformin 850 mg

Metformin 500 mg

Metformin 850

Sitagliptin 100 mg

Placebo

Total

Overall Participants Analyzed
[Units: Participants]

122

125

126

124

120

127

744

Age
[Units: Years]
Mean (Standard Deviation)

52.6 (11.3)

52.4 (9.3)

52.6 (9.5)

53.0 (10.3)

51.7 (10.2)

53.6 (9.7)

52.7 (10.0)

Sex: Female, Male
[Units: Participants]
Count of Participants

Female

37 30.3%

58 46.4%

57 45.2%

49 39.5%

46 38.3%

40 31.5%

287 38.6%

Male

85 69.7%

67 53.6%

69 54.8%

75 60.5%

74 61.7%

87 68.5%

457 61.4%

Hemoglobin A1c (A1C)
[Units: Percent of glycosylated hemoglobin]
Mean (Standard Deviation)

8.46 (0.97)

8.66 (0.95)

8.69 (0.99)

8.67 (1.08)

8.74 (1.14)

8.97 (1.05)

8.70 (1.04)

Fasting plasma glucose (FPG)
[Units: mg/dL]
Mean (Standard Deviation)

175.6 (40.6)

181.9 (43.0)

184.6 (46.8)

183.5 (47.7)

182.5 (44.0)

185.8 (47.3)

182.3 (45.0)

2-hour post meal glucose (2-h PMG) ^[1]
[Units: mg/dL]
Mean (Standard Deviation)

292.7 (81.2)

292.9 (68.4)

303.2 (74.1)

298.8 (74.6)

297.7 (74.7)

308.3 (83.6)

299.0 (76.2)

^[1]	Participants with data: sita50/met500, n=121; sita50/met850, n=125; met500, n=125; met850, n=123; sita100, n=119; placebo; n=126; total, n=739

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and Week 24 ]

Measure Type	Primary
Measure Title	Change From Baseline in Hemoglobin A1C (A1C) at Week 24
Measure Description	A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Time Frame	Baseline and Week 24

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).

Reporting Groups

	Description
Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
Sitagliptin 50 mg + Metformin 850 mg	Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
Metformin 500 mg	Metformin 500 mg twice daily
Metformin 850 mg	Metformin 850 mg twice daily
Sitagliptin 100 mg	Sitagliptin 100 mg once daily
Placebo	Matching placebo to sitagliptin and/or metformin

Measured Values

	Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg + Metformin 850 mg	Metformin 500 mg	Metformin 850 mg	Sitagliptin 100 mg	Placebo
Participants Analyzed [Units: Participants]	118	114	116	117	113	117
Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [Units: Percent of glycosylated hemoglobin] Least Squares Mean (95% Confidence Interval)	-1.67 (-1.92 to -1.43)	-1.83 (-2.07 to -1.58)	-1.29 (-1.54 to -1.04)	-1.56 (-1.80 to -1.32)	-0.99 (-1.24 to -0.75)	-0.59 (-0.84 to -0.34)

Statistical Analysis 1 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Metformin 850 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.087
Difference in Least Squares Mean ^[5]	-0.27
95% Confidence Interval	-0.58 to 0.04

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Sitagliptin 100 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-0.84
95% Confidence Interval	-1.15 to -0.52

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Metformin 500 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.014
Difference in Least Squares Mean ^[5]	-0.39
95% Confidence Interval	-0.69 to -0.08

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Sitagliptin 100 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-0.68
95% Confidence Interval	-0.99 to -0.37

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-1.24
95% Confidence Interval	-1.55 to -0.93

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Metformin 850 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-0.97
95% Confidence Interval	-1.28 to -0.66

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-1.08
95% Confidence Interval	-1.39 to -0.78

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Metformin 500 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-0.70
95% Confidence Interval	-1.01 to -0.39

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 100 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.011
Difference in Least Squares Mean ^[5]	-0.40
95% Confidence Interval	-0.71 to -0.09

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 100 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 10 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Metformin 850 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	0.008
Difference in least squares mean ^[5]	-0.36
95% Confidence Interval	-0.62 to -0.09

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 11 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Sitagliptin 100 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-0.87
95% Confidence Interval	-1.13 to -0.60

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 12 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Metformin 500 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	0.007
Difference in Least Squares Mean ^[5]	-0.36
95% Confidence Interval	-0.63 to -0.10

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 13 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Sitagliptin 100 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-0.61
95% Confidence Interval	-0.88 to -0.35

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 14 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-1.25
95% Confidence Interval	-1.52 to -0.99

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 15 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Metformin 850 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-0.90
95% Confidence Interval	-1.16 to -0.63

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 16 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-1.00
95% Confidence Interval	-1.26 to -0.74

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 17 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Metformin 500 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-0.64
95% Confidence Interval	-0.90 to -0.37

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 18 for Change From Baseline in Hemoglobin A1C (A1C) at Week 24

Groups ^[1]	Sitagliptin 100 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Regression, Robust
P Value ^[4]	0.004
Difference in Least Squares Mean ^[5]	-0.39
95% Confidence Interval	-0.65 to -0.12

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary:

Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24 [ Time Frame: Baseline and Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24
Measure Description	Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.
Time Frame	Baseline and Week 24

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for 2-h PMG subsequent to at least 1 dose of study treatment, or lacked baseline data for 2-h PMG. Last observation carried forward (missing data approach).

Reporting Groups

	Description
Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
Sitagliptin 50 mg + Metformin 850 mg	Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
Metformin 500 mg	Metformin 500 mg twice daily
Metformin 850	Metformin 850 mg twice daily
Sitagliptin 100 mg	Sitagliptin 100 mg once daily
Placebo	Matching placebo to sitagliptin and/or metformin

Measured Values

	Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg + Metformin 850 mg	Metformin 500 mg	Metformin 850	Sitagliptin 100 mg	Placebo
Participants Analyzed [Units: Participants]	110	110	112	108	107	107
Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24 [Units: mg/dL] Least Squares Mean (95% Confidence Interval)	-97.05 (-109.01 to -85.09)	-109.46 (-121.47 to -97.44)	-65.67 (-77.76 to -53.58)	-90.93 (-103.04 to -78.83)	-48.11 (-60.37 to -35.85)	-21.88 (-34.33 to -9.43)

Statistical Analysis 1 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Metformin 850
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.017
Difference in Least Squares Mean ^[5]	-18.52
95% Confidence Interval	-33.75 to -3.29

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Sitagliptin 100 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-61.34
95% Confidence Interval	-76.61 to -46.07

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Metformin 500 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-31.38
95% Confidence Interval	-46.49 to -16.28

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Sitagliptin 100 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-48.94
95% Confidence Interval	-64.21 to -33.67

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-87.57
95% Confidence Interval	-102.87 to -72.27

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Metformin 850 vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-69.05
95% Confidence Interval	-84.41 to -53.70

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, metformin 850 mg vs. placebo
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-75.17
95% Confidence Interval	-90.47 to -59.87

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Metformin 500 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-43.79
95% Confidence Interval	-58.99 to -28.58

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, metformin 500 mg vs. placebo
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

Groups ^[1]	Sitagliptin 100 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-26.23
95% Confidence Interval	-41.62 to -10.84

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 100 mg vs. placebo
[5]	Other relevant estimation information:
	No text entered.

3. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Measure Description	Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
Time Frame	Baseline and Week 24

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for FPG. Last observation carried forward (missing data approach).

Reporting Groups

	Description
Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
Sitagliptin 50 mg + Metformin 850 mg	Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
Metformin 500 mg	Metformin 500 mg twice daily
Metformin 850	Metformin 850 mg twice daily
Sitagliptin 100 mg	Sitagliptin 100 mg once daily
Placebo	Matching placebo to sitagliptin and/or metformin

Measured Values

	Sitagliptin 50 mg + Metformin 500 mg	Sitagliptin 50 mg + Metformin 850 mg	Metformin 500 mg	Metformin 850	Sitagliptin 100 mg	Placebo
Participants Analyzed [Units: Participants]	118	116	119	119	114	119
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [Units: mg/dL] Least Squares Mean (95% Confidence Interval)	-39.38 (-46.29 to -32.47)	-47.74 (-54.73 to -40.75)	-33.66 (-40.66 to -26.66)	-39.63 (-46.50 to -32.76)	-21.86 (-28.92 to -14.80)	-11.93 (-18.94 to -4.92)

Statistical Analysis 1 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Metformin 850
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.069
Difference in Least Squares Mean ^[5]	-8.11
95% Confidence Interval	-16.86 to 0.64

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Sitagliptin 100 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-25.88
95% Confidence Interval	-34.72 to -17.04

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Metformin 500 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.198
Difference in Least Squares Mean ^[5]	-5.72
95% Confidence Interval	-14.44 to 3.00

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Sitagliptin 100 mg
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-17.53
95% Confidence Interval	-26.33 to -8.72

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 850 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-35.81
95% Confidence Interval	-44.56 to -27.06

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Metformin 850 vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-27.70
95% Confidence Interval	-36.40 to -19.00

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, metformin 850 mg vs. placebo.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Sitagliptin 50 mg + Metformin 500 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-27.45
95% Confidence Interval	-36.18 to -18.73

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Metformin 500 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Difference in Least Squares Mean ^[5]	-21.73
95% Confidence Interval	-30.42 to -13.04

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, metformin 500 mg vs. placebo.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Groups ^[1]	Sitagliptin 100 mg vs. Placebo
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	ANCOVA
P Value ^[4]	0.027
Difference in Least Squares Mean ^[5]	-9.93
95% Confidence Interval	-18.72 to -1.14

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Pairwise comparison, sitagliptin 100 mg vs. placebo.
[5]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.

Results Point of Contact:

Name/Title: Senior Vice President,Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

Publications of Results:

Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01076088 History of Changes
Other Study ID Numbers:	0431-121 2010_514 ( Other Identifier: Merck Registration Number )
Study First Received:	February 24, 2010
Results First Received:	December 17, 2013
Last Updated:	April 27, 2017

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