A Study of BMS-512148 (Dapagliflozin) in Patients With Ty... | NCT01137474

ID	Type	Description	Link
2010-019797-32	EudraCT Number

Name	Class
Bristol-Myers Squibb	INDUSTRY

A Study of BMS-512148 (Dapagliflozin) in Patients With Ty... | NCT01137474 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapagliflozin, 10 mg	Experimental	Oral tablets administered as 10 mg once daily for up to 12 weeks	Drug: Dapagliflozin
Placebo-matching dapagliflozin	Placebo Comparator	Oral tablets administered once daily in the morning	Drug: Placebo-matching dapagliflozin
Dapagliflozin, 2. 5 mg	Experimental	Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)	Drug: Dapagliflozin
Dapagliflozin, 5 mg	Experimental	Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)	Drug: Dapagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks	Dapagliflozin, 10 mg Dapagliflozin, 2. 5 mg Dapagliflozin, 5 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12	Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.	From Baseline to Week 12
Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12	HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.	From Baseline to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)	Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.

Eligibility Module

Eligibility Criteria

Key inclusion criteria

Participants willing and able to give signed and written informed consent
Males and females, aged 18 to 89 years, who have type 2 diabetes with inadequate glycemic control (hemoglobin A1c between 7% and 10.5%) and uncontrolled hypertension (seated systolic blood pressure of 140 to 165 mm Hg and seated diastolic blood pressure 85 to 105 mm Hg)
Mean 24-hour BP>=130/80 mmHg determined by ABPM
Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks (12 weeks for thiazolidinedione) or a stable daily dose of insulin as monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks
C-peptide level ≥0.8 ng/mL
Body mass index ≤ 45.0 kg/m^2

Key exclusion criteria

Aspartate aminotransferase or alanine aminotransferase level >3*upper limit of normal (ULN)
Serum total bilirubin level >1.5*ULN
Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
Estimated creatinine clearance of <60 mL/min
Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
Creatine kinase >3*ULN
Positive for hepatitis B surface antigen
Positive for antihepatitis C virus antibody
Abnormal free T4 value
History of diabetes insipidus
Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
History of diabetic ketoacidosis or hyperosmolar nonketotic coma
History of malignant and accelerated hypertension
Known or suspected secondary hypertension
Any of the following within 6 months of enrollment visit:
- Myocardial infarction
- Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
- Unstable angina
- Unstable congestive heart disease or New York Heart Association Class III or IV
- Transient ischemic attack or significant cerebrovascular disease
- Unstable or previously undiagnosed arrhythmia

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University Of Alabama At Birmingham		Birmingham	Alabama	35294	United States
Horizon Research Group, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38770818	Derived	Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Label	URL
Redacted\_Protocol	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0003 subjects FG0015 subjects FG0021 subjects FG0033 subjects
Withdrawal by Subject		FG0007 subjects FG0012 subjects FG0026 subjects FG0039 subjects
No longer met study criteria		FG0006 subjects FG0011 subjects FG0020 subjects FG0035 subjects
Lost to Follow-up		FG0005 subjects FG0011 subjects FG0020 subjects FG0032 subjects
Lack of Efficacy		FG0000 subjects FG0010 subjects FG0020 subjects FG0032 subjects
Other		FG0003 subjects FG0011 subjects FG0020 subjects FG0030 subjects
Pregnancy		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects
Administrative reason by sponsor		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
BG001	Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)	Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
BG002	Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)	Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
BG003	Dapagliflozin 10 mg	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

Younger than 65 years

Title	Measurements
	BG000259 BG001141 BG002142 BG003

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000140 BG00176 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000241 BG001105 BG002

Body Mass Index

Number

Participants

Title

Denominators

Categories

Less than 25 kg/m^2

Title	Measurements
	BG00028 BG00120 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12

Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.

This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.

Posted

Mean

Standard Error

mm Hg

From Baseline to Week 12

ID	Title	Description
OG000	Dapagliflozin 10 mg	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
OG001	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.

Units	Counts
Participants	OG000280 OG001279

Title

Denominators

Categories

Title	Measurements
	OG000-10.40± 0.8822 OG001-7.34± 0.8812

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	Change from baseline to week 12 calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis. With 253 patients per group, there is >80% power to detect a difference of 3.5 mm Hg at alpha=0.05, assuming a common SD of 14 mm Hg.	Longitudinal repeated measures analysis	Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.	0.0010	Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.	Mean Difference (Final Values)	-3.05	Standard Error of the Mean	0.9251	2-Sided	95

Primary

Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12

HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.

Posted

Mean

Standard Error

Percent

From Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
OG001	Dapagliflozin 10 mg	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.

Secondary

Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)

Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.

Posted

Mean

Standard Error

mm Hg

From Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
OG001	Dapagliflozin 10 mg

Secondary

Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12

All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.

Posted

Mean

Standard Error

mm Hg

From Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
OG001	Dapagliflozin 10 mg	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.

Secondary

Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])

Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.

Posted

Mean

Standard Error

mm Hg

From Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
OG001	Dapagliflozin 10 mg

Secondary

Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12

Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.

Posted

Mean

Standard Error

mg/dL

From Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
OG001	Dapagliflozin 10 mg	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Placebo	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.	4	311	311
EG001	Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)	Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.	3	166	166
EG002	Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)	Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.	2	165	165
EG003	Dapagliflozin 10 mg	Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.	2	302	302

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Mastoiditis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG0031 affected302 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0010 affected166 at risk EG0021 affected165 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0010 affected166 at risk EG0021 affected165 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0010 affected166 at risk EG0021 affected165 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0011 affected166 at risk EG0020 affected165 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0011 affected166 at risk EG0020 affected165 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0011 affected166 at risk EG0020 affected165 at risk EG003
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Abscess intestinal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Appendiceal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0011 affected166 at risk EG0020 affected165 at risk EG003
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Appendicitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0011 affected166 at risk EG0020 affected165 at risk EG003
Otitis media	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0010 affected166 at risk EG0020 affected165 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected311 at risk EG0011 affected166 at risk EG0020 affected165 at risk EG003

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	Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. With 253 subjects per group, there is >98% power to detect a difference of 0.4% at a=0.05, assuming a common SD of 1.1%.	Longitudinal repeated measures analysis	Only Week 12 data are presented; data from all weeks in the double-blind treatment period were included in the longitudinal repeated measures model	<0.0001	Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.	Mean Difference (Final Values)	-0.46	Standard Error of the Mean	0.0673	2-Sided	95	-0.59	-0.33				No	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	Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.	ANCOVA	Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.	0.0043	Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.	Mean Difference (Final Values)	-2.89	Standard Error of the Mean	1.0091	2-Sided	95	-4.88	-0.91				No	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	Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis.	Longitudinal repeated measures analysis	Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.	0.0843	Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.	Mean Difference (Final Values)	-1.00	Standard Error of the Mean	0.5811	2-Sided	95	-2.15	0.14				No	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	Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.	ANCOVA			Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.	Mean Difference (Final Values)	-0.62	Standard Error of the Mean	0.6866	2-Sided	95	-1.96	0.73				No	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	Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction.	Longitudinal repeated measures analysis	Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.		Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.	Mean Difference (Final Values)	-0.32	Standard Error of the Mean	0.0717	2-Sided	95	-0.46	-0.18				No	Superiority or Other

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases