Trial Outcomes & Findings for Value of Glycated Albumin in Intervention of Glycemic Control in Chinese Patients With Type 2 Diabetes (NCT NCT05227677)

NCT ID: NCT05227677

Last Updated: 2025-12-04

Results Overview

To compare the achievement rate of HbA1c(\<7%) between the two groups at 12-week of follow-up.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-12-04

Participant Flow

Out of 207 participants, 11 were excluded for reasons such as not meeting criteria for newly diagnosed type 2 diabetes, unsuitable for observation, age requirements, protocol violation, and mistaken inclusion. 196 participants were successfully screened, and 200 were randomly assigned to the study. Four participants violated criteria but were still included. The study groups consisted of 98 in the intervention group and 102 in the control group.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	98	102
Overall Study COMPLETED	86	93
Overall Study NOT COMPLETED	12	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GA Guided Anti-diabetic Therapy Adjustment n=98 Participants 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.	Current Guidelines to Adjust Treatment n=101 Participants 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.	Total n=199 Participants Total of all reporting groups
Age, Continuous	49.3 years STANDARD_DEVIATION 10.76 • n=98 Participants	50.7 years STANDARD_DEVIATION 10.65 • n=101 Participants	50.0 years STANDARD_DEVIATION 10.70 • n=199 Participants
Sex: Female, Male Female	32 Participants n=98 Participants	36 Participants n=101 Participants	68 Participants n=199 Participants
Sex: Female, Male Male	66 Participants n=98 Participants	65 Participants n=101 Participants	131 Participants n=199 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	98 participants n=98 Participants	101 participants n=101 Participants	199 participants n=199 Participants
BMI	28.2 Kg/m^2 STANDARD_DEVIATION 3.5 • n=98 Participants	27.7 Kg/m^2 STANDARD_DEVIATION 4.5 • n=101 Participants	27.9 Kg/m^2 STANDARD_DEVIATION 4.0 • n=199 Participants
Waist circumference	97.0 cm STANDARD_DEVIATION 8.4 • n=98 Participants	94.7 cm STANDARD_DEVIATION 11.2 • n=101 Participants	95.9 cm STANDARD_DEVIATION 10.0 • n=199 Participants
Systolic blood pressure	135 mmHg STANDARD_DEVIATION 17 • n=98 Participants	133 mmHg STANDARD_DEVIATION 13 • n=101 Participants	134 mmHg STANDARD_DEVIATION 16 • n=199 Participants
Diastolic blood pressure	86 mmHg STANDARD_DEVIATION 11 • n=98 Participants	85 mmHg STANDARD_DEVIATION 11 • n=101 Participants	85 mmHg STANDARD_DEVIATION 11 • n=199 Participants
Participants with Hyperlipidemia	57 Participants n=98 Participants	55 Participants n=101 Participants	112 Participants n=199 Participants
Participants with Hypertension	36 Participants n=98 Participants	41 Participants n=101 Participants	77 Participants n=199 Participants
Fasting Blood Glucose	9.93 mmol/L STANDARD_DEVIATION 1.93 • n=98 Participants	9.31 mmol/L STANDARD_DEVIATION 1.83 • n=101 Participants	9.63 mmol/L STANDARD_DEVIATION 1.89 • n=199 Participants
HbA1c	8.9 % STANDARD_DEVIATION 0.9 • n=98 Participants	8.7 % STANDARD_DEVIATION 0.8 • n=101 Participants	8.8 % STANDARD_DEVIATION 8.9 • n=199 Participants
Glycated Albumin	22.5 % STANDARD_DEVIATION 4.1 • n=98 Participants	21.9 % STANDARD_DEVIATION 3.5 • n=101 Participants	22.2 % STANDARD_DEVIATION 3.8 • n=199 Participants
Fasting serum insulin	11.73 μU/mL n=98 Participants	11.55 μU/mL n=101 Participants	11.70 μU/mL n=199 Participants
Fasting serum C peptide	2.91 ng/mL n=98 Participants	2.88 ng/mL n=101 Participants	2.89 ng/mL n=199 Participants
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	5.30 FINS(μIU)×FPG(mmol/L)/22.5 n=98 Participants	4.80 FINS(μIU)×FPG(mmol/L)/22.5 n=101 Participants	5.15 FINS(μIU)×FPG(mmol/L)/22.5 n=199 Participants
HOMA-β	37.6 20×FINS(μIU/mL)/(FPG(mmol/L)-3.5) n=98 Participants	43.7 20×FINS(μIU/mL)/(FPG(mmol/L)-3.5) n=101 Participants	40.0 20×FINS(μIU/mL)/(FPG(mmol/L)-3.5) n=199 Participants
Leucocyte	6.65 cells*10^9/L STANDARD_DEVIATION 1.46 • n=98 Participants	7.18 cells*10^9/L STANDARD_DEVIATION 1.97 • n=101 Participants	6.92 cells*10^9/L STANDARD_DEVIATION 1.76 • n=199 Participants
Erythrocyte	5.02 cells*10^9/L STANDARD_DEVIATION 0.44 • n=98 Participants	5.06 cells*10^9/L STANDARD_DEVIATION 0.52 • n=101 Participants	5.05 cells*10^9/L STANDARD_DEVIATION 0.47 • n=199 Participants
Platelet	245 cells*10^9/L STANDARD_DEVIATION 63.4 • n=98 Participants	241 cells*10^9/L STANDARD_DEVIATION 59.0 • n=101 Participants	242.8 cells*10^9/L STANDARD_DEVIATION 61.2 • n=199 Participants
Hemoglobin	153.5 g/L STANDARD_DEVIATION 16.02 • n=98 Participants	153.8 g/L STANDARD_DEVIATION 14.26 • n=101 Participants	153.8 g/L STANDARD_DEVIATION 15.00 • n=199 Participants
Alanine Aminotransferase (ALT)	33.3 U/L n=98 Participants	35.4 U/L n=101 Participants	34.9 U/L n=199 Participants
Serum Creatinine	66.5 μmol/L STANDARD_DEVIATION 14.1 • n=98 Participants	65.2 μmol/L STANDARD_DEVIATION 15.0 • n=101 Participants	65.8 μmol/L STANDARD_DEVIATION 14.6 • n=199 Participants
Estimated Glomerular Filtration Rate (eGFR)	106.3 mL/min/1.73m2 STANDARD_DEVIATION 18.1 • n=98 Participants	106.0 mL/min/1.73m2 STANDARD_DEVIATION 18.3 • n=101 Participants	106.3 mL/min/1.73m2 STANDARD_DEVIATION 18.0 • n=199 Participants
Serum uric acid	348.4 μmol/L n=98 Participants	323.0 μmol/L n=101 Participants	338.5 μmol/L n=199 Participants
Total cholesterol	5.36 mmol/L STANDARD_DEVIATION 1.11 • n=98 Participants	5.17 mmol/L STANDARD_DEVIATION 0.99 • n=101 Participants	5.26 mmol/L STANDARD_DEVIATION 1.02 • n=199 Participants
triglyceride	2.08 mmol/L n=98 Participants	1.92 mmol/L n=101 Participants	2.00 mmol/L n=199 Participants
HDL-C	1.14 mmol/L STANDARD_DEVIATION 0.25 • n=98 Participants	1.18 mmol/L STANDARD_DEVIATION 0.26 • n=101 Participants	1.16 mmol/L STANDARD_DEVIATION 0.25 • n=199 Participants
LDL-C	3.43 mmol/L STANDARD_DEVIATION 1.00 • n=98 Participants	3.25 mmol/L STANDARD_DEVIATION 0.86 • n=101 Participants	3.34 mmol/L STANDARD_DEVIATION 0.93 • n=199 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Analysis dataset included two sets. Full analysis set (FAS) was defined as participants who were randomized, met the study inclusion criteria, and had baseline measurements of the primary efficacy endpoint. Per protocol set (PPS) was defined as subjects with good compliance in FAS and no significant protocol deviations that affect the primary efficacy evaluation.

To compare the achievement rate of HbA1c(\<7%) between the two groups at 12-week of follow-up.

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=98 Participants 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.	current guidelines to adjust treatment n=101 Participants 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.
The Achievement Rate of HbA1c (<7%) FAS analysis	63 Participants	65 Participants
The Achievement Rate of HbA1c (<7%) PPS analysis	58 Participants	64 Participants

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=98 Participants 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.	current guidelines to adjust treatment n=101 Participants 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.
The Achievement Rate of HbA1c(<6.5%) FAS analysis	35 Participants	24 Participants
The Achievement Rate of HbA1c(<6.5%) PPS analysis	32 Participants	23 Participants

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=98 Participants 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.	current guidelines to adjust treatment n=101 Participants 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.
The Achievement Rate of HbA1c (<6%) FAS analysis	13 Participants	8 Participants
The Achievement Rate of HbA1c (<6%) PPS analysis	13 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=93 Participants 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.
Change in HbA1c Levels FAS analysis	-2.3 percentage of HbA1c Interval -2.9 to -1.5	-1.7 percentage of HbA1c Interval -2.5 to -1.2
Change in HbA1c Levels PPS analysis	-2.3 percentage of HbA1c Interval -3.0 to -1.5	-1.7 percentage of HbA1c Interval -2.5 to -1.2

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=93 Participants 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.
Rate of Change in HbA1c Levels FAS analysis	-24.794 Percent change Standard Deviation 9.8781	-21.574 Percent change Standard Deviation 9.2575
Rate of Change in HbA1c Levels PPS analysis	-24.971 Percent change Standard Deviation 10.0353	-21.474 Percent change Standard Deviation 9.0570

SECONDARY outcome

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

To compare the rate of hypoglycemic events between the two groups

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=98 Participants 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.	current guidelines to adjust treatment n=101 Participants 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.
Rate of Hypoglycemic Events FAS analysis at V3	1 Participants	1 Participants
Rate of Hypoglycemic Events FAS analysis at V4	2 Participants	1 Participants
Rate of Hypoglycemic Events PPS analysis at V3	1 Participants	1 Participants
Rate of Hypoglycemic Events PPS analysis at V4	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=91 Participants 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.
Change in HOMA-β Levels FAS analysis	33.60 percentage of beta cell function Interval 15.7 to 59.0	21.50 percentage of beta cell function Interval 9.5 to 47.0
Change in HOMA-β Levels PPS analysis	33.70 percentage of beta cell function Interval 15.7 to 59.3	21.50 percentage of beta cell function Interval 10.4 to 43.8

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=91 Participants 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.
Percent Change in HOMA-β Levels FAS analysis	89.10 Percent change in HOMA-β Interval 33.3 to 184.0	66.30 Percent change in HOMA-β Interval 23.2 to 121.5
Percent Change in HOMA-β Levels PPS analysis	90.30 Percent change in HOMA-β Interval 33.3 to 207.4	66.30 Percent change in HOMA-β Interval 24.0 to 116.0

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=91 Participants 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.
Change in HOMA-IR Levels FAS analysis	-2.10 index Interval -3.3 to -0.5	-1.10 index Interval -2.6 to 0.2
Change in HOMA-IR Levels PPS analysis	-2.30 index Interval -3.3 to -0.6	-1.10 index Interval -2.6 to 0.1

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=91 Participants 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.
Percent Change in HOMA-IR Levels FAS analysis	-42.35 Percent Change in HOMA-IR Interval -57.4 to -14.3	-27.50 Percent Change in HOMA-IR Interval -51.4 to 5.6
Percent Change in HOMA-IR Levels PPS analysis	-43.80 Percent Change in HOMA-IR Interval -57.4 to -20.8	-30.00 Percent Change in HOMA-IR Interval -51.4 to 4.3

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=93 Participants 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.
Change in Weight FAS analysis	-2.45 Weight Change(kg) Interval -5.0 to -0.7	-1.50 Weight Change(kg) Interval -3.2 to 0.0
Change in Weight PPS analysis	-2.40 Weight Change(kg) Interval -5.1 to -0.7	-1.50 Weight Change(kg) Interval -3.3 to 0.0

SECONDARY outcome

Timeframe: 12weeks

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=93 Participants 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.
Percent Change in Weight FAS analysis	-2.940 Percent Change in Weight Interval -6.52 to -0.72	-1.670 Percent Change in Weight Interval -4.41 to 0.0
Percent Change in Weight PPS analysis	-2.930 Percent Change in Weight Interval -6.94 to -0.72	-1.830 Percent Change in Weight Interval -4.61 to 0.0

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=93 Participants 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.
Change in Waist Circumferences PPS analysis	-4.00 Change in Waist circumferences (cm) Interval -7.0 to -1.0	-2.00 Change in Waist circumferences (cm) Interval -5.5 to 0.0
Change in Waist Circumferences FAS analysis	-4.00 Change in Waist circumferences (cm) Interval -7.0 to -1.0	-2.00 Change in Waist circumferences (cm) Interval -5.2 to 0.0

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=93 Participants 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.
Percent Change in Waist Circumferences PPS analysis	-3.960 Percent change in waist circumferences Interval -6.6 to -1.12	-2.170 Percent change in waist circumferences Interval -5.36 to 0.0
Percent Change in Waist Circumferences FAS analysis	-4.00 Percent change in waist circumferences Interval -7.05 to -1.17	-2.020 Percent change in waist circumferences Interval -5.28 to 0.0

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=93 Participants 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.
Change in BMI FAS analysis	-0.85 Change in BMI (kg/m^2) Interval -1.9 to -0.2	-0.50 Change in BMI (kg/m^2) Interval -1.2 to 0.0
Change in BMI PPS analysis	-0.80 Change in BMI (kg/m^2) Interval -1.9 to -0.2	-0.50 Change in BMI (kg/m^2) Interval -1.2 to 0.0

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	GA guided anti-diabetic therapy adjustment n=86 Participants 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.	current guidelines to adjust treatment n=93 Participants 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.
Percent Change in BMI FAS analysis	-3.140 Percent Change in BMI Interval -6.69 to -0.74	-1.790 Percent Change in BMI Interval -4.51 to 0.0
Percent Change in BMI PPS analysis	-3.000 Percent Change in BMI Interval -7.09 to -0.74	-1.820 Percent Change in BMI Interval -4.56 to 0.0

Adverse Events

GA guided anti-diabetic therapy adjustment

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

current guidelines to adjust treatment

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GA guided anti-diabetic therapy adjustment n=98 participants at risk 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.	current guidelines to adjust treatment n=102 participants at risk 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.
Metabolism and nutrition disorders hypokalemia	0.00% 0/98 • 12 weeks	0.98% 1/102 • Number of events 1 • 12 weeks
Respiratory, thoracic and mediastinal disorders breast cancer	0.00% 0/98 • 12 weeks	0.98% 1/102 • Number of events 1 • 12 weeks

Other adverse events

Other adverse events
Measure	GA guided anti-diabetic therapy adjustment n=98 participants at risk 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.	current guidelines to adjust treatment n=102 participants at risk 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.
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	4.1% 4/98 • 12 weeks	0.00% 0/102 • 12 weeks
Metabolism and nutrition disorders hyperuricemia	10.2% 10/98 • 12 weeks	4.9% 5/102 • 12 weeks
Metabolism and nutrition disorders dyslipidemia	4.1% 4/98 • 12 weeks	3.9% 4/102 • 12 weeks

Additional Information

Takuji Kohzuma

Nagase Diagnostics Co.,Ltd.

Phone: 09080045463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place