A Study in China Evaluating the Safety and Efficacy of Ad... | NCT01590771

A Study in China Evaluating the Safety and Efficacy of Ad... | NCT01590771 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sitagliptin	Experimental	Sitagliptin 100 mg once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during run-in period.	Drug: Sitagliptin Drug: Gliclazide Drug: Glimepiride Drug: Metformin
Placebo	Placebo Comparator	Matching placebo once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.	Drug: Placebo Drug: Gliclazide Drug: Glimepiride Drug: Metformin

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin	Drug	Sitagliptin 100 mg oral tablet once daily for 24 weeks	Sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin	A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.	Baseline and Week 24
Number of Participants Who Experienced an Adverse Event	An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.	Up to 26 weeks
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.	Up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin	This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.	Baseline and Week 24
Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

has T2DM
is currently on a stable regimen of gliclazide or glimepiride, either alone or in combination with metformin for ≥ 10 weeks
has a Visit 1/Screening HbA1C between 7.5% and 11.0%
is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication

Exclusion Criteria:

has a history of type 1 diabetes mellitus or a history of ketoacidosis
has been treated with any antihyperglycemic therapies other than a sulfonylurea (alone or with metformin) within the prior 12 weeks or has ever

been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue

has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, gliclazide/glimepiride, or metformin
is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months
has undergone a surgical procedure within 4 weeks or has planned major surgery during the study
has a medical history of active liver disease
has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder
has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status
has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg
has human immunodeficiency virus (HIV)
has severe peripheral vascular disease
is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
has a clinically important hematological disorder (such as aplastic anemia,

myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication
is a user of recreational or illicit drugs or has had a recent history of drug abuse

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27502307	Result	Ba J, Han P, Yuan G, Mo Z, Pan C, Wu F, Xu L, Hanson ME, Engel SS, Shankar RR. Randomized trial assessing the safety and efficacy of sitagliptin in Chinese patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea alone or combined with metformin. J Diabetes. 2017 Jul;9(7):667-676. doi: 10.1111/1753-0407.12456. Epub 2016 Sep 13.

ID	Type	URL	Comment
	CSR Synopsis	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Other Protocol Specified Criteria		FG0005 subjects FG00114 subjects
Withdrawal by Subject		FG0008 subjects FG00115 subjects
Protocol Violation		FG0001 subjects FG0012 subjects
Lost to Follow-up		FG0001 subjects FG0011 subjects
Lack of Efficacy		FG0001 subjects FG0010 subjects
Adverse Event		FG0003 subjects FG0017 subjects

Arm/Group Information

ID	Title	Description
BG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
BG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000249 BG001249 BG002498

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00057.5± 9.5 BG00156.5± 9.3 BG00257.0± 9.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000132 BG001117 BG002

Hemoglobin A1c (A1C)

Mean

Standard Deviation

Percent of glycosylated hemoglobin (A1C)

Title

Denominators

Categories

Title	Measurements
	BG0008.61± 1.06 BG0018.48± 0.91 BG002

2-hour post meal glucose (2-hr PMG)

Sitagliptin, n=248; placebo, n=249; total, n=497

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000296.5± 68.0 BG001290.2± 72.4

Fasting plasma glucose (FPG)

Sitagliptin, n=249; placebo, n=249; total, n=498

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000181.5± 40.9 BG001179.8± 40.7

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 From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin

A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.

Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

Percent of glycosylated hemoglobin (A1C)

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants	OG000243 OG001236

Title

Denominators

Categories

Title	Measurements
	OG000-0.88(-0.99 to -0.76) OG001-0.27(-0.38 to -0.15)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.001	The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline A1C value.	Robust regression	-0.61			2-Sided	95	-0.77	-0.44			Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline A1C value.		Superiority or Other

Secondary

Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin

This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.

Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Secondary

Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin

This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.

Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Secondary

Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin

A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.

Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

Percent of glycosylated hemoglobin (A1C)

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Secondary

Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone

A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.

Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

Percent of glycosylated hemoglobin (A1C)

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Secondary

Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin

This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Secondary

Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone

This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Secondary

Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin

This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Secondary

Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone

This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Primary

Number of Participants Who Experienced an Adverse Event

An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.

All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.

Posted

Number

Participants

Up to 26 weeks

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Units	Counts
Participants

Primary

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Posted

Number

Participants

Up to 24 weeks

ID	Title	Description
OG000	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
OG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

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	Sitagliptin	Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.			7	248	54	248
EG001	Placebo	Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.			7	249	40	249

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected248 at risk EG0010 events0 affected249 at risk
Erysipelas	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected248 at risk EG0010 events0 affected249 at risk
Lung infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected248 at risk EG0010 events0 affected249 at risk
Mastitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected248 at risk EG0011 events1 affected249 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected248 at risk EG0011 events1 affected249 at risk
Blood glucose increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected248 at risk EG0010 events0 affected249 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected248 at risk EG0011 events1 affected249 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected248 at risk EG0011 events1 affected249 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected248 at risk EG0011 events1 affected249 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected248 at risk EG0010 events0 affected249 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected248 at risk EG0011 events1 affected249 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected248 at risk EG0011 events1 affected249 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected248 at risk EG0010 events0 affected249 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected248 at risk EG0010 events0 affected249 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00014 events14 affected248 at risk EG00111 events11 affected249 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0008 events8 affected248 at risk EG00115 events15 affected249 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG00076 events35 affected248 at risk EG00128 events17 affected249 at risk

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013453	Sulfonylurea Compounds
D014508	Urea
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D001645	Biguanides
D006146	Guanidines
D000578	Amidines

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.001	The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline 2-hr PMG value.	Difference in least squares mean	-32.9			2-Sided	95	-45.4	-20.4					Superiority or Other

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		Robust regression		<0.001	Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline FPG value.	Estimate difference	-16.8			2-Sided	95	-23.3	-10.2					Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.001	The ANCOVA model controlled for treatment and baseline A1C value.	Difference in least squares mean	-0.41			2-Sided	95	-0.63	-0.20					Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.001	The ANCOVA model controlled for treatment and baseline A1C value.	Difference in least squares mean	-0.80			2-Sided	95	-1.07	-0.53					Superiority or Other

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		Robust regression		<0.001	Based on robust regression using M-estimation with terms for treatment and baseline 2-hr PMG value.	Estimate difference	-27.2			2-Sided	95	-41.2	-13.2					Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.001	The ANCOVA model controlled for treatment and baseline 2-hr PMG value.	Difference in least squares mean	-37.7			2-Sided	95	-56.9	-18.4					Superiority or Other

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		Robust Regression		<0.001	Based on robust regression using M-estimation with terms for treatment and baseline FPG value.	Estimate Difference	-16.5			2-Sided	95	-25.3	-7.8					Superiority or Other

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		Robust Regression		<0.001	Based on robust regression using M-estimation with terms for treatment and baseline FPG value.	Estimate Difference	-17.0			2-Sided	95	-26.9	-7.1					Superiority or Other

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

ID	Term
D000068900	Sitagliptin Phosphate
D005907	Gliclazide
C057619	glimepiride
D008687	Metformin