Value of Glycated Albumin in Intervention of Glycemic Con... | NCT05227677

Status Module

Oversight Module

Description Module

Detailed Description

At present, glycosylated hemoglobin (HbA1c) is widely used as the gold standard for evaluating glycemic control. However, as a marker of average blood glucose level, HbA1c has some limitations. HbA1c is affected by many conditions, such as hemolytic anemia, recent blood loss or blood transfusion, chronic renal failure, the use of erythropoietin or other drugs affecting hematopoiesis, and the presence of variant hemoglobin. In addition, HbA1c represents the average blood glucose level in the last 2-3 months, in patients who need adjusting hypoglycemic regimen, A1c was not a sensitive marker. Therefore, finding clinical markers that can timely guide the adjustment and evaluate therapeutic effects is an urgent demand for individualized treatment of diabetes.

Glycated albumin (GA) has been available in clinic for sixteen years, yet the clinical value of routine measurements of GA in the care of diabetic patients is still uncertain. Previous studies have shown that the GA half-life is 17-19 days, so the serum GA level can reflect the average blood glucose level and the recent blood glucose changes and the extent of the changes in the last 2~3 weeks of diabetes, and is not affected by age, gender, diet, drugs and glycemic fluctuation. A recent short-term study found that in newly diagnosed type 2 diabetic patients with initial therapy and in patients with type 2 diabetes and unsatisfactory glucose control and need intensifying treatment, changes in GA could predict changes in HbA1c levels after 3 months. Therefore, investigators undertake this study to determine whether knowledge of GA values and adjusting anti-diabetic regimens according to GA values will result in improved glycemic control in newly diagnosed type 2 diabetes mellitus (T2DM).

This multicenter randomized controlled clinical study will be conducted in 10 hospitals in China. A total of 200 patients with newly diagnosed T2DM will be 1:1 randomly assigned to two groups: intervention group (GA) and control group (NC). In this study, the clinical related indexes such as GA, fasting blood glucose, HbA1c, fasting C-peptide, fasting insulin, liver and kidney function, blood routine, blood uric acid and blood lipid were measured at baseline. The GA serum was frozen and not used as the basis for initial treatment. All the patients will be treated with antidiabetic therapy according to guideline for prevention and treatment of type 2 diabetes in China (2020) and followed up for 12 weeks. The GA concentration will be measured at 4-week intervals. In GA group, the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. In NC group, investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. At the end of 12 weeks, A1c and other metabolic indexes will be measured again. All the anti-diabetic drugs are permitted in this study except sulfonylureas, glinides, insulin and insulin analogues.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GA guided anti-diabetic therapy adjustment	Experimental	The GA values will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.	Other: GA guided anti-diabetic therapy adjustment
current guidelines to adjust treatment	Active Comparator	The GA values will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.	Other: current guidelines to adjust treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GA guided anti-diabetic therapy adjustment	Other	The GA values will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.

Outcomes Module

Measure	Description	Time Frame
The Achievement Rate of HbA1c (<7%)	To compare the achievement rate of HbA1c(<7%) between the two groups at 12-week of follow-up.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
The Achievement Rate of HbA1c(<6.5%)	To compare the achievement rate of HbA1c(<6.5%) between the two groups at 12-week of follow-up.	12 weeks
The Achievement Rate of HbA1c (<6%)	To compare the achievement rate of HbA1c(<6%) between the two groups at 12-week of follow-up.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-70 years of age
newly diagnosed T2DM or duration of T2DM less than 1 year and without anti-diabetic medications for 3 months prior to screening
HbA1c ≥7.5% and <10.5%

Exclusion Criteria:

Requiring treatment of proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot, diabetic ketoacidosis, or hyperglycemic hyperosmolar status in recent 3 months prior to screening.
The following history or conditions in recent 6 months prior to screening: (i) decompensated cardiac insufficiency (NYHA class III or IV); (ii)myocardial infarction, coronary artery bypass grafting or coronary stent implantation; (iii) uncontrolled severe arrhythmia and is not suitable to participate in this study evaluated by the investigator; (iv) hemorrhagic stroke or ischemic stroke and is not suitable to participate in this study evaluated by the investigator.
Laboratory indicators meet one of the following criteria: (i) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3× upper limit of normal(ULN); (ii) total bilirubin > 2× ULN; (iii) hemoglobin <100g/L; (iv)total protein <60g/L; (v)albumin <30g/L; (vi) glomerular filtration rate(eGFR)<60 ml min-1 per 1.73 m2.
Thalassemia, hemolytic anemia and other diseases that may cause erythrocyte instability and affect the measurement of HbA1c.
Uncontrolled thyroid dysfunction.
Systemic corticosteroids treatment in recent 1 month prior to screening (exception of inhalation or local external treatment).
Pregnancy or lactating.
Two or more episodes of severe hypoglycemia in recent 1 year prior to screening.
Patient who need to initiate treatment with sulfonylureas, glinides, insulin or insulin analogues evaluated by the investigators.
Patient is being treated with calcium dobesilate or has a disease requiring calcium dobesilate treatment, or may be treated with calcium dobesilate in the near future evaluated by the investigators.
Patients considered unsuitable for observation by investigators.

Name	Affiliation	Role
Linong Ji, Professor	Peking University People's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The third people's hospital of DATONG		Datong	Shanxi		China
Beijing Haidian Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31771933	Background	Ren Q, Ji LN, Lu JM, Li YF, Li QM, Lin SS, Lv XF, Wang L, Xu Y, Guo XH, Guo QY, Ma L, Du J, Chen YL, Zhao CL, Zhang QL, She QM, Jiao XM, Lu MH, Sun XM, Gao Y, Zhang J. Search for clinical predictors of good glycemic control in patients starting or intensifying oral hypoglycemic pharmacological therapy: A multicenter prospective cohort study. J Diabetes Complications. 2020 Feb;34(2):107464. doi: 10.1016/j.jdiacomp.2019.107464. Epub 2019 Oct 20.
27496253

Label	URL
Articles related to clinical trials	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GA guided anti-diabetic therapy adjustment	The Glycated ALbumin (GA) value will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 28, 2021	Jun 26, 2025

Arm/Group Information

ID	Title	Description
BG000	GA Guided Anti-diabetic Therapy Adjustment	The Glycated Albumin (GA) value will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA values is higher than 16% at 4 weeks.
BG001	Current Guidelines to Adjust Treatment	The GA value will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00098 BG001101 BG002199

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

FAS analysis

- ParticipantsOG00098
- ParticipantsOG001101

Title	Measurements
	OG00063

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		Chi-squared		0.9917	The threshold for statical significance was p=0.05.													Superiority	FAS analysis
OG000 OG001	PPS analysis	Chi-squared

Secondary

The Achievement Rate of HbA1c(<6.5%)

To compare the achievement rate of HbA1c(<6.5%) between the two groups at 12-week of follow-up.

Posted

Count of Participants

Participants

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

The Achievement Rate of HbA1c (<6%)

To compare the achievement rate of HbA1c(<6%) between the two groups at 12-week of follow-up.

Posted

Count of Participants

Participants

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Change in HbA1c Levels

To compare the change of HbA1c levels between the two groups after 12-week of follow-up.

At V5, HbA1c measurements were unavailable for 12 participants in the GA intervention group and 8 participants in the control group. Consequently, the FAS analysis of HbA1c changes was conducted using data from 86 participants in the GA intervention group and 93 participants in the control group.

Posted

Median

Inter-Quartile Range

percentage of HbA1c

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Rate of Change in HbA1c Levels

To compare the rate of change in HbA1c measurements between the two groups after 12-week of follow-up.

Posted

Mean

Standard Deviation

Percent change

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Rate of Hypoglycemic Events

To compare the rate of hypoglycemic events between the two groups

Posted

Count of Participants

Participants

at visit 3(4 weeks) and visit 4(8 weeks)

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Change in HOMA-β Levels

To compare the change in HOMA-β levels between the two groups after 12-week of follow-up.

At V5, HOMA-β data were missing for 12 participants in the GA intervention group (GA) and 10 in the control group, resulting in FAS analysis using 86 GA and 91 control participants. In the PPS group, data were missing for 0 in GA and 2 in control, so PPS analysis included 79 GA and 89 control participants.

Posted

Median

Inter-Quartile Range

percentage of beta cell function

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Percent Change in HOMA-β Levels

To compare the rate in change of HOMA-β levels between the two groups after 12-week of follow-up.

Posted

Median

Inter-Quartile Range

Percent change in HOMA-β

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Change in HOMA-IR Levels

To compare the change in HOMA-IR between two groups after 12 weeks of follow-up.

The HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) index is a widely used surrogate marker for assessing insulin resistance. It is calculated as:

HOMA-IR = (Fasting Insulin [μU/mL] × Fasting Glucose [mg/dL]) / 405

Interpretation:

Lower HOMA-IR values indicate better insulin sensitivity. Higher HOMA-IR values suggest increased insulin resistance.

Typical Reference Ranges:

1.0-1.9: Normal range 2.0-2.9: Early insulin resistance

≥3.0: Significant insulin resistance

Note: These ranges may vary depending on population characteristics and laboratory standards. There is no universally defined theoretical minimum or maximum value. Clinical thresholds such as ≥2.5 or ≥3.0 are commonly used to indicate insulin resistance in adults.

At V5, HOMA-IR data were missing for 12 participants in the GA intervention group (GA) and 10 in the control group, resulting in FAS analysis using 86 GA and 91 control participants. In the PPS group, data were missing for 0 in GA and 2 in control, so PPS analysis included 79 GA and 89 control participants.

Posted

Median

Inter-Quartile Range

index

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.

Secondary

Percent Change in HOMA-IR Levels

To compare the rate of change in HOMA-IR levels between the two groups after 12-week of follow-up.

Posted

Median

Inter-Quartile Range

Percent Change in HOMA-IR

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Change in Weight

To compare the change in weight between two groups after 12 weeks of follow-up.

At V5, Weight data were missing for 12 participants in the GA intervention group (GA) and 8 in the control group, resulting in FAS analysis using 86 GA and 93 control participants. In the PPS group, no data were missing for in GA and in control, so PPS analysis included 79 GA and 91 control participants.

Posted

Median

Inter-Quartile Range

Weight Change(kg)

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Percent Change in Weight

To compare the rate of change in weight between the two groups at 12-week of follow-up.

Posted

Median

Inter-Quartile Range

Percent Change in Weight

12weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Change in Waist Circumferences

To compare the change in waist circumferences between two groups after 12 weeks of follow-up.

At V5, Waist circumference data were missing for 12 participants in the GA intervention group (GA) and 8 in the control group, resulting in FAS analysis using 86 GA and 93 control participants. In the PPS group, no data were missing for in GA and in control, so PPS analysis included 79 GA and 91 control participants.

Posted

Median

Inter-Quartile Range

Change in Waist circumferences (cm)

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Percent Change in Waist Circumferences

To compare the rate of change in waist circumferences between the two groups after 12-week of follow-up.

At V5, waist circumference data were missing for 12 participants in the GA intervention group (GA) and 8 in the control group, resulting in FAS analysis using 86 GA and 93 control participants. In the PPS group, no data were missing for in GA and in control, so PPS analysis included 79 GA and 91 control participants.

Posted

Median

Inter-Quartile Range

Percent change in waist circumferences

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Change in BMI

To compare the change in BMI between two groups after 12 weeks of follow-up.

Posted

Median

Inter-Quartile Range

Change in BMI (kg/m^2)

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

Secondary

Percent Change in BMI

To compare the rate of change in BMI between the two groups after 12-week of follow-up.

Posted

Median

Inter-Quartile Range

Percent Change in BMI

12 weeks

ID	Title	Description
OG000	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
OG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.

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	GA guided anti-diabetic therapy adjustment	The GA concentration will be measured at 4-week intervals and the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. GA guided anti-diabetic therapy adjustment: The GA concentration will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.	0	98	0	98	18	98
EG001	current guidelines to adjust treatment	The GA concentration will be measured at 4-week intervals，but investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. current guidelines to adjust treatment: The GA concentration will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.	0	102	2	102	9	102

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
hyperuricemia	Metabolism and nutrition disorders	MedDRA/C [27.0]	Systematic Assessment	EG00010 affected98 at risk EG0015 affected102 at risk
dyslipidemia	Metabolism and nutrition disorders	MedDRA/C [27.0]	Systematic Assessment	EG0004 affected98 at risk EG0014 affected102 at risk
upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA/C [27.0]	Systematic Assessment	EG0004 affected98 at risk EG0010 affected102 at risk

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

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
hypokalemia	Metabolism and nutrition disorders	MedDRA/C [27.0]	Systematic Assessment		EG0000 events0 affected98 at risk EG0011 events1 affected102 at risk
breast cancer	Respiratory, thoracic and mediastinal disorders	MedDRA/C [27.0]	Systematic Assessment		EG0000 events0 affected98 at risk EG0011 events1 affected102 at risk