Trial Outcomes & Findings for 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy (NCT NCT02243176)

Last Updated: 2017-04-14

Results Overview

Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

689 participants

Primary outcome timeframe

From baseline to 24 week

Results posted on

2017-04-14

Participant Flow

A total of 689 patients were enrolled into this study from 35 sites in China. The enrolled patient number ranged from 10 to 58 among 24 centers, and 2 to 9 patients from eight centers, none was enrolled in 3 centers. The enrolment period was from 24 Sep 2014 to 29 Sep 2015.

A total of 201 patients were enrolled but not randomized: 171 patients did not meet eligibility criteria, and 24 patients were voluntary discontinuations, two patients developed study-specific withdrawal criteria, one patient lost follow-up, and three patient failed due to other reasons

Participant milestones

Participant milestones
Measure	Saxagliptin The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Overall Study STARTED	244	244
Overall Study COMPLETED	230	229
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Saxagliptin The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Overall Study Other reason	1	2
Overall Study protocol specified withdrawal critera	1	3
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	8	7
Overall Study Adverse Event	2	2

Baseline Characteristics

24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saxagliptin n=238 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=243 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.	Total n=481 Participants Total of all reporting groups
Age, Continuous	54.7 Years STANDARD_DEVIATION 10.51 • n=93 Participants	56.5 Years STANDARD_DEVIATION 10.81 • n=4 Participants	55.6 Years STANDARD_DEVIATION 10.69 • n=27 Participants
Sex: Female, Male Female	91 Participants n=93 Participants	105 Participants n=4 Participants	196 Participants n=27 Participants
Sex: Female, Male Male	147 Participants n=93 Participants	138 Participants n=4 Participants	285 Participants n=27 Participants
Race/Ethnicity, Customized Asian (China Mainland)	238 Participants n=93 Participants	243 Participants n=4 Participants	481 Participants n=27 Participants
Height	166.3 cm STANDARD_DEVIATION 8 • n=93 Participants	165.9 cm STANDARD_DEVIATION 7.75 • n=4 Participants	166.1 cm STANDARD_DEVIATION 7.87 • n=27 Participants
Weight	73.3 kg STANDARD_DEVIATION 12.61 • n=93 Participants	72.6 kg STANDARD_DEVIATION 12.27 • n=4 Participants	72.9 kg STANDARD_DEVIATION 12.43 • n=27 Participants
BMI	26.4 kg/m^2 STANDARD_DEVIATION 3.47 • n=93 Participants	26.3 kg/m^2 STANDARD_DEVIATION 3.49 • n=4 Participants	26.3 kg/m^2 STANDARD_DEVIATION 3.48 • n=27 Participants
Duration of diabetes mellitus (years)	5.1 Years STANDARD_DEVIATION 4.4 • n=93 Participants	5.3 Years STANDARD_DEVIATION 4.76 • n=4 Participants	5.2 Years STANDARD_DEVIATION 4.58 • n=27 Participants
Type of diabetes mellitus Type 2	238 Participants n=93 Participants	243 Participants n=4 Participants	481 Participants n=27 Participants
Type of diabetes mellitus Other	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Currently taking antidiabetic medication	238 Participants n=93 Participants	243 Participants n=4 Participants	481 Participants n=27 Participants
Any diabetes mellitus complications No	214 Participants n=93 Participants	221 Participants n=4 Participants	435 Participants n=27 Participants
Any diabetes mellitus complications Yes	24 Participants n=93 Participants	22 Participants n=4 Participants	46 Participants n=27 Participants
Any relevant medical conditions Yes	119 Participants n=93 Participants	125 Participants n=4 Participants	244 Participants n=27 Participants
Any relevant medical conditions No	65 Participants n=93 Participants	64 Participants n=4 Participants	129 Participants n=27 Participants
Any relevant medical conditions Missing	54 Participants n=93 Participants	54 Participants n=4 Participants	108 Participants n=27 Participants
Any current medication，excluding antidiabetic drugs Yes	59 Participants n=93 Participants	73 Participants n=4 Participants	132 Participants n=27 Participants
Any current medication，excluding antidiabetic drugs No	179 Participants n=93 Participants	170 Participants n=4 Participants	349 Participants n=27 Participants
HbA1c (%)	8.23 % STANDARD_DEVIATION 0.85 • n=93 Participants	8.16 % STANDARD_DEVIATION 0.81 • n=4 Participants	8.20 % STANDARD_DEVIATION 0.83 • n=27 Participants
FPG	9.01 mmol/l STANDARD_DEVIATION 2.14 • n=93 Participants	8.81 mmol/l STANDARD_DEVIATION 1.95 • n=4 Participants	8.90 mmol/l STANDARD_DEVIATION 2.04 • n=27 Participants
2hPPG	11.17 mmol/l STANDARD_DEVIATION 2.82 • n=93 Participants	10.25 mmol/l STANDARD_DEVIATION 2.89 • n=4 Participants	10.7 mmol/l STANDARD_DEVIATION 2.89 • n=27 Participants
Triglycerides	1.99 mmol/l STANDARD_DEVIATION 1.12 • n=93 Participants	1.96 mmol/l STANDARD_DEVIATION 1.38 • n=4 Participants	1.97 mmol/l STANDARD_DEVIATION 1.26 • n=27 Participants
TC	4.78 mmol/l STANDARD_DEVIATION 1.07 • n=93 Participants	4.82 mmol/l STANDARD_DEVIATION 0.94 • n=4 Participants	4.80 mmol/l STANDARD_DEVIATION 1.01 • n=27 Participants
LDL	2.73 mmol/l STANDARD_DEVIATION 0.89 • n=93 Participants	2.77 mmol/l STANDARD_DEVIATION 0.79 • n=4 Participants	2.75 mmol/l STANDARD_DEVIATION 0.84 • n=27 Participants
HDL	1.16 mmol/l STANDARD_DEVIATION 0.29 • n=93 Participants	1.2 mmol/l STANDARD_DEVIATION 0.3 • n=4 Participants	1.18 mmol/l STANDARD_DEVIATION 0.3 • n=27 Participants

PRIMARY outcome

Timeframe: From baseline to 24 week

Population: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Outcome measures

Outcome measures
Measure	Saxagliptin n=238 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=243 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Absolute Change From Baseline in HbA1c at Week 24 (DAO)	-0.82 % (HbA1c) Standard Error 0.06	-0.78 % (HbA1c) Standard Error 0.06

PRIMARY outcome

Timeframe: From baseline to 24 week

Population: The Per Protocol analysis set was a subset of the Full analysis set that included subjects who did not have significant protocol deviations that affect the study outcome. The exclusions from the PP analysis set was determined prior to database lock.

The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.

Outcome measures

Outcome measures
Measure	Saxagliptin n=219 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=204 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Absolute Change From Baseline in HbA1c at Week 24 (DAO)	-0.83 % (HbA1c) Standard Error 0.06	-0.80 % (HbA1c) Standard Error 0.07

SECONDARY outcome

Timeframe: 24 weeks

Population: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.

Outcome measures

Outcome measures
Measure	Saxagliptin n=238 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=243 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Proportion (%) of Patients With Any GI Adverse Events NO	94.5 percentage of participants	75.3 percentage of participants
Proportion (%) of Patients With Any GI Adverse Events YES	5.5 percentage of participants	24.7 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c\<7.0%

Outcome measures

Outcome measures
Measure	Saxagliptin n=230 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=229 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%	38.3 percentage of participants	41.5 percentage of participants

SECONDARY outcome

Timeframe: Whole study duration

Population: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c\<7.0% without GI adverse events.

Outcome measures

Outcome measures
Measure	Saxagliptin n=230 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=229 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events	37.0 percentage of participants	28.8 percentage of participants

SECONDARY outcome

Timeframe: From baseline to 24 week

Population: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Outcome measures

Outcome measures
Measure	Saxagliptin n=238 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=243 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Change From Baseline in Fasting Plasma Glucose (FPG)	-0.99 mmol/l Standard Error 0.13	-1.01 mmol/l Standard Error 0.13

SECONDARY outcome

Timeframe: From baseline to 24 week

Population: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Outcome measures

Outcome measures
Measure	Saxagliptin n=227 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=232 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Change From Baseline in 2H Postprandial Glucose (2HPPG)	-0.77 mmol/l Standard Error 0.176	-1.07 mmol/l Standard Error 0.174

SECONDARY outcome

Timeframe: From baseline to 24 week

Population: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24

Outcome measures

Outcome measures
Measure	Saxagliptin n=227 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=225 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Change From Baseline in HOMA-β	20.56 mU/mmol Standard Error 5.932	13.08 mU/mmol Standard Error 5.958

SECONDARY outcome

Timeframe: From baseline to 24 week

Population: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Outcome measures

Outcome measures
Measure	Saxagliptin n=238 Participants The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=243 Participants Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Change From Baseline in Body Weight	-1.36 kg Standard Error 0.18	-2.05 kg Standard Error 0.18

Adverse Events

Saxagliptin

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Acarbose

Serious events: 2 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Saxagliptin n=241 participants at risk The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=244 participants at risk Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Infections and infestations herpes zoster	0.41% 1/241 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.00% 0/244 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Hepatobiliary disorders cholecystitis	0.00% 0/241 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.41% 1/244 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Hepatobiliary disorders Cholelithiasis	0.00% 0/241 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.41% 1/244 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Renal and urinary disorders Chronic kidney disease	0.00% 0/241 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.41% 1/244 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Infections and infestations Urinary tract infection	0.00% 0/241 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.41% 1/244 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Cardiac disorders Coronary artery disease	0.41% 1/241 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.41% 1/244 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
General disorders Oedema peripheral	0.41% 1/241 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.00% 0/244 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Hepatobiliary disorders Hepatic function abnormal	0.41% 1/241 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.00% 0/244 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Infections and infestations Infection	0.41% 1/241 • Number of events 1 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	0.00% 0/244 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.

Other adverse events

Other adverse events
Measure	Saxagliptin n=241 participants at risk The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.	Acarbose n=244 participants at risk Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Metabolism and nutrition disorders Hyperlipidaemia	3.7% 9/241 • Number of events 9 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	7.0% 17/244 • Number of events 17 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Gastrointestinal disorders Abdominal distension	1.2% 3/241 • Number of events 3 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	10.2% 25/244 • Number of events 25 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.
Gastrointestinal disorders Flatulence	0.00% 0/241 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.	7.4% 18/244 • Number of events 18 • Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject. Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.

Additional Information

Xia, Zhang

ASTRAZENECA INVESTMENT (CHINA) CO., LTD.

Phone: +86 21 6030 2288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60