Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, glycated albumin, intervention, anti-diabetic regimens, Hemoglobin A1c
Brief summary
HbA1c is widely used as the gold standard for evaluating glycemic control. However, in patients who need adjusting hypoglycemic regimen, A1c was not a sensitive marker. In comparison, serum GA level can reflect the average blood glucose level in the last 2\ 3 weeks of diabetes. 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 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 12-week of follow-up，investigators compare the achievement rate of HbA1c(\<7%) between the two groups.
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.
Interventions
OTHERGA guided anti-diabetic therapy adjustment
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.
OTHERcurrent guidelines to adjust treatment
The GA values 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.
Sponsors
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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). After testing baseline metabolic indexes including A1c, 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Achievement Rate of HbA1c (<7%) | 12 weeks | To compare the achievement rate of HbA1c(\<7%) between the two groups at 12-week of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Achievement Rate of HbA1c (<6%) | 12 weeks | To compare the achievement rate of HbA1c(\<6%) between the two groups at 12-week of follow-up. |
| Change in HbA1c Levels | 12 weeks | To compare the change of HbA1c levels between the two groups after 12-week of follow-up. |
| Rate of Change in HbA1c Levels | 12 weeks | To compare the rate of change in HbA1c measurements between the two groups after 12-week of follow-up. |
| Rate of Hypoglycemic Events | at visit 3(4 weeks) and visit 4(8 weeks) | To compare the rate of hypoglycemic events between the two groups |
| Change in HOMA-β Levels | 12 weeks | To compare the change in HOMA-β levels between the two groups after 12-week of follow-up. |
| Percent Change in HOMA-β Levels | 12 weeks | To compare the rate in change of HOMA-β levels between the two groups after 12-week of follow-up. |
| Change in HOMA-IR Levels | 12 weeks | 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. |
| The Achievement Rate of HbA1c(<6.5%) | 12 weeks | To compare the achievement rate of HbA1c(\<6.5%) between the two groups at 12-week of follow-up. |
| Change in Weight | 12 weeks | To compare the change in weight between two groups after 12 weeks of follow-up. |
| Percent Change in Weight | 12weeks | To compare the rate of change in weight between the two groups at 12-week of follow-up. |
| Change in Waist Circumferences | 12 weeks | To compare the change in waist circumferences between two groups after 12 weeks of follow-up. |
| Percent Change in Waist Circumferences | 12 weeks | To compare the rate of change in waist circumferences between the two groups after 12-week of follow-up. |
| Change in BMI | 12 weeks | To compare the change in BMI between two groups after 12 weeks of follow-up. |
| Percent Change in BMI | 12 weeks | To compare the rate of change in BMI between the two groups after 12-week of follow-up. |
| Percent Change in HOMA-IR Levels | 12 weeks | To compare the rate of change in HOMA-IR levels between the two groups after 12-week of follow-up. |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| 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. | 101 |
| Total | 199 |
Baseline characteristics
| Characteristic | GA Guided Anti-diabetic Therapy Adjustment | Current Guidelines to Adjust Treatment | Total |
|---|---|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 10.76 | 50.7 years STANDARD_DEVIATION 10.65 | 50.0 years STANDARD_DEVIATION 10.7 |
| Alanine Aminotransferase (ALT) | 33.3 U/L | 35.4 U/L | 34.9 U/L |
| BMI | 28.2 Kg/m^2 STANDARD_DEVIATION 3.5 | 27.7 Kg/m^2 STANDARD_DEVIATION 4.5 | 27.9 Kg/m^2 STANDARD_DEVIATION 4 |
| Diastolic blood pressure | 86 mmHg STANDARD_DEVIATION 11 | 85 mmHg STANDARD_DEVIATION 11 | 85 mmHg STANDARD_DEVIATION 11 |
| Erythrocyte | 5.02 cells*10^9/L STANDARD_DEVIATION 0.44 | 5.06 cells*10^9/L STANDARD_DEVIATION 0.52 | 5.05 cells*10^9/L STANDARD_DEVIATION 0.47 |
| Estimated Glomerular Filtration Rate (eGFR) | 106.3 mL/min/1.73m2 STANDARD_DEVIATION 18.1 | 106.0 mL/min/1.73m2 STANDARD_DEVIATION 18.3 | 106.3 mL/min/1.73m2 STANDARD_DEVIATION 18 |
| Fasting Blood Glucose | 9.93 mmol/L STANDARD_DEVIATION 1.93 | 9.31 mmol/L STANDARD_DEVIATION 1.83 | 9.63 mmol/L STANDARD_DEVIATION 1.89 |
| Fasting serum C peptide | 2.91 ng/mL | 2.88 ng/mL | 2.89 ng/mL |
| Fasting serum insulin | 11.73 μU/mL | 11.55 μU/mL | 11.70 μU/mL |
| Glycated Albumin | 22.5 % STANDARD_DEVIATION 4.1 | 21.9 % STANDARD_DEVIATION 3.5 | 22.2 % STANDARD_DEVIATION 3.8 |
| HbA1c | 8.9 % STANDARD_DEVIATION 0.9 | 8.7 % STANDARD_DEVIATION 0.8 | 8.8 % STANDARD_DEVIATION 8.9 |
| HDL-C | 1.14 mmol/L STANDARD_DEVIATION 0.25 | 1.18 mmol/L STANDARD_DEVIATION 0.26 | 1.16 mmol/L STANDARD_DEVIATION 0.25 |
| Hemoglobin | 153.5 g/L STANDARD_DEVIATION 16.02 | 153.8 g/L STANDARD_DEVIATION 14.26 | 153.8 g/L STANDARD_DEVIATION 15 |
| HOMA-β | 37.6 20×FINS(μIU/mL)/(FPG(mmol/L)-3.5) | 43.7 20×FINS(μIU/mL)/(FPG(mmol/L)-3.5) | 40.0 20×FINS(μIU/mL)/(FPG(mmol/L)-3.5) |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 5.30 FINS(μIU)×FPG(mmol/L)/22.5 | 4.80 FINS(μIU)×FPG(mmol/L)/22.5 | 5.15 FINS(μIU)×FPG(mmol/L)/22.5 |
| LDL-C | 3.43 mmol/L STANDARD_DEVIATION 1 | 3.25 mmol/L STANDARD_DEVIATION 0.86 | 3.34 mmol/L STANDARD_DEVIATION 0.93 |
| Leucocyte | 6.65 cells*10^9/L STANDARD_DEVIATION 1.46 | 7.18 cells*10^9/L STANDARD_DEVIATION 1.97 | 6.92 cells*10^9/L STANDARD_DEVIATION 1.76 |
| Participants with Hyperlipidemia | 57 Participants | 55 Participants | 112 Participants |
| Participants with Hypertension | 36 Participants | 41 Participants | 77 Participants |
| Platelet | 245 cells*10^9/L STANDARD_DEVIATION 63.4 | 241 cells*10^9/L STANDARD_DEVIATION 59 | 242.8 cells*10^9/L STANDARD_DEVIATION 61.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 98 participants | 101 participants | 199 participants |
| Serum Creatinine | 66.5 μmol/L STANDARD_DEVIATION 14.1 | 65.2 μmol/L STANDARD_DEVIATION 15 | 65.8 μmol/L STANDARD_DEVIATION 14.6 |
| Serum uric acid | 348.4 μmol/L | 323.0 μmol/L | 338.5 μmol/L |
| Sex: Female, Male Female | 32 Participants | 36 Participants | 68 Participants |
| Sex: Female, Male Male | 66 Participants | 65 Participants | 131 Participants |
| Systolic blood pressure | 135 mmHg STANDARD_DEVIATION 17 | 133 mmHg STANDARD_DEVIATION 13 | 134 mmHg STANDARD_DEVIATION 16 |
| Total cholesterol | 5.36 mmol/L STANDARD_DEVIATION 1.11 | 5.17 mmol/L STANDARD_DEVIATION 0.99 | 5.26 mmol/L STANDARD_DEVIATION 1.02 |
| triglyceride | 2.08 mmol/L | 1.92 mmol/L | 2.00 mmol/L |
| Waist circumference | 97.0 cm STANDARD_DEVIATION 8.4 | 94.7 cm STANDARD_DEVIATION 11.2 | 95.9 cm STANDARD_DEVIATION 10 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 102 |
| other Total, other adverse events | 18 / 98 | 9 / 102 |
| serious Total, serious adverse events | 0 / 98 | 2 / 102 |
Outcome results
Primary
The Achievement Rate of HbA1c (<7%)
To compare the achievement rate of HbA1c(\<7%) between the two groups at 12-week of follow-up.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | The Achievement Rate of HbA1c (<7%) | FAS analysis | 63 Participants |
| GA guided anti-diabetic therapy adjustment | The Achievement Rate of HbA1c (<7%) | PPS analysis | 58 Participants |
| current guidelines to adjust treatment | The Achievement Rate of HbA1c (<7%) | FAS analysis | 65 Participants |
| current guidelines to adjust treatment | The Achievement Rate of HbA1c (<7%) | PPS analysis | 64 Participants |
p-value: 0.9917Chi-squared
Comparison: PPS analysisp-value: 0.6555Chi-squared
Secondary
Change in BMI
To compare the change in BMI between two groups after 12 weeks of follow-up.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Change in BMI | PPS analysis | -0.80 Change in BMI (kg/m^2) |
| GA guided anti-diabetic therapy adjustment | Change in BMI | FAS analysis | -0.85 Change in BMI (kg/m^2) |
| current guidelines to adjust treatment | Change in BMI | FAS analysis | -0.50 Change in BMI (kg/m^2) |
| current guidelines to adjust treatment | Change in BMI | PPS analysis | -0.50 Change in BMI (kg/m^2) |
p-value: 0.0087Wilcoxon (Mann-Whitney)
p-value: 0.0152Wilcoxon (Mann-Whitney)
Secondary
Change in HbA1c Levels
To compare the change of HbA1c levels between the two groups after 12-week of follow-up.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Change in HbA1c Levels | FAS analysis | -2.3 percentage of HbA1c |
| GA guided anti-diabetic therapy adjustment | Change in HbA1c Levels | PPS analysis | -2.3 percentage of HbA1c |
| current guidelines to adjust treatment | Change in HbA1c Levels | FAS analysis | -1.7 percentage of HbA1c |
| current guidelines to adjust treatment | Change in HbA1c Levels | PPS analysis | -1.7 percentage of HbA1c |
Comparison: FAS analysisp-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.0147Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Change in HOMA-IR Levels | FAS analysis | -2.10 index |
| GA guided anti-diabetic therapy adjustment | Change in HOMA-IR Levels | PPS analysis | -2.30 index |
| current guidelines to adjust treatment | Change in HOMA-IR Levels | FAS analysis | -1.10 index |
| current guidelines to adjust treatment | Change in HOMA-IR Levels | PPS analysis | -1.10 index |
Comparison: FAS analysisp-value: 0.0303Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.0264Wilcoxon (Mann-Whitney)
Secondary
Change in HOMA-β Levels
To compare the change in HOMA-β levels between the two groups after 12-week of follow-up.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Change in HOMA-β Levels | FAS analysis | 33.60 percentage of beta cell function |
| GA guided anti-diabetic therapy adjustment | Change in HOMA-β Levels | PPS analysis | 33.70 percentage of beta cell function |
| current guidelines to adjust treatment | Change in HOMA-β Levels | FAS analysis | 21.50 percentage of beta cell function |
| current guidelines to adjust treatment | Change in HOMA-β Levels | PPS analysis | 21.50 percentage of beta cell function |
Comparison: FAS analysisp-value: 0.0404Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.033Wilcoxon (Mann-Whitney)
Secondary
Change in Waist Circumferences
To compare the change in waist circumferences between two groups after 12 weeks of follow-up.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Change in Waist Circumferences | FAS analysis | -4.00 Change in Waist circumferences (cm) |
| GA guided anti-diabetic therapy adjustment | Change in Waist Circumferences | PPS analysis | -4.00 Change in Waist circumferences (cm) |
| current guidelines to adjust treatment | Change in Waist Circumferences | FAS analysis | -2.00 Change in Waist circumferences (cm) |
| current guidelines to adjust treatment | Change in Waist Circumferences | PPS analysis | -2.00 Change in Waist circumferences (cm) |
p-value: 0.0057Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.0175Wilcoxon (Mann-Whitney)
Secondary
Change in Weight
To compare the change in weight between two groups after 12 weeks of follow-up.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Change in Weight | FAS analysis | -2.45 Weight Change(kg) |
| GA guided anti-diabetic therapy adjustment | Change in Weight | PPS analysis | -2.40 Weight Change(kg) |
| current guidelines to adjust treatment | Change in Weight | FAS analysis | -1.50 Weight Change(kg) |
| current guidelines to adjust treatment | Change in Weight | PPS analysis | -1.50 Weight Change(kg) |
Comparison: FAS analysisp-value: 0.0086Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.0156Wilcoxon (Mann-Whitney)
Secondary
Percent Change in BMI
To compare the rate of change in BMI between the two groups after 12-week of follow-up.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Percent Change in BMI | FAS analysis | -3.140 Percent Change in BMI |
| GA guided anti-diabetic therapy adjustment | Percent Change in BMI | PPS analysis | -3.000 Percent Change in BMI |
| current guidelines to adjust treatment | Percent Change in BMI | FAS analysis | -1.790 Percent Change in BMI |
| current guidelines to adjust treatment | Percent Change in BMI | PPS analysis | -1.820 Percent Change in BMI |
p-value: 0.0103Wilcoxon (Mann-Whitney)
p-value: 0.0176Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Percent Change in HOMA-IR Levels | FAS analysis | -42.35 Percent Change in HOMA-IR |
| GA guided anti-diabetic therapy adjustment | Percent Change in HOMA-IR Levels | PPS analysis | -43.80 Percent Change in HOMA-IR |
| current guidelines to adjust treatment | Percent Change in HOMA-IR Levels | FAS analysis | -27.50 Percent Change in HOMA-IR |
| current guidelines to adjust treatment | Percent Change in HOMA-IR Levels | PPS analysis | -30.00 Percent Change in HOMA-IR |
Comparison: FAS analysisp-value: 0.0374Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.0313Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Percent Change in HOMA-β Levels | PPS analysis | 90.30 Percent change in HOMA-β |
| GA guided anti-diabetic therapy adjustment | Percent Change in HOMA-β Levels | FAS analysis | 89.10 Percent change in HOMA-β |
| current guidelines to adjust treatment | Percent Change in HOMA-β Levels | FAS analysis | 66.30 Percent change in HOMA-β |
| current guidelines to adjust treatment | Percent Change in HOMA-β Levels | PPS analysis | 66.30 Percent change in HOMA-β |
Comparison: FAS analysisp-value: 0.0408Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.0322Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Percent Change in Waist Circumferences | FAS analysis | -4.00 Percent change in waist circumferences |
| GA guided anti-diabetic therapy adjustment | Percent Change in Waist Circumferences | PPS analysis | -3.960 Percent change in waist circumferences |
| current guidelines to adjust treatment | Percent Change in Waist Circumferences | FAS analysis | -2.020 Percent change in waist circumferences |
| current guidelines to adjust treatment | Percent Change in Waist Circumferences | PPS analysis | -2.170 Percent change in waist circumferences |
Comparison: FAS analysisp-value: 0.0065Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.0188Wilcoxon (Mann-Whitney)
Secondary
Percent Change in Weight
To compare the rate of change in weight between the two groups at 12-week of follow-up.
Time frame: 12weeks
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Percent Change in Weight | FAS analysis | -2.940 Percent Change in Weight |
| GA guided anti-diabetic therapy adjustment | Percent Change in Weight | PPS analysis | -2.930 Percent Change in Weight |
| current guidelines to adjust treatment | Percent Change in Weight | FAS analysis | -1.670 Percent Change in Weight |
| current guidelines to adjust treatment | Percent Change in Weight | PPS analysis | -1.830 Percent Change in Weight |
Comparison: FAS analysisp-value: 0.0118Wilcoxon (Mann-Whitney)
Comparison: PPS analysisp-value: 0.0191Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Rate of Change in HbA1c Levels | FAS analysis | -24.794 Percent change | Standard Deviation 9.8781 |
| GA guided anti-diabetic therapy adjustment | Rate of Change in HbA1c Levels | PPS analysis | -24.971 Percent change | Standard Deviation 10.0353 |
| current guidelines to adjust treatment | Rate of Change in HbA1c Levels | FAS analysis | -21.574 Percent change | Standard Deviation 9.2575 |
| current guidelines to adjust treatment | Rate of Change in HbA1c Levels | PPS analysis | -21.474 Percent change | Standard Deviation 9.057 |
Comparison: FAS analysisp-value: 0.0256t-test, 2 sided
Comparison: PPS analysisp-value: 0.0181t-test, 2 sided
Secondary
Rate of Hypoglycemic Events
To compare the rate of hypoglycemic events between the two groups
Time frame: at visit 3(4 weeks) and visit 4(8 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | Rate of Hypoglycemic Events | FAS analysis at V3 | 1 Participants |
| GA guided anti-diabetic therapy adjustment | Rate of Hypoglycemic Events | PPS analysis at V3 | 1 Participants |
| GA guided anti-diabetic therapy adjustment | Rate of Hypoglycemic Events | FAS analysis at V4 | 2 Participants |
| GA guided anti-diabetic therapy adjustment | Rate of Hypoglycemic Events | PPS analysis at V4 | 2 Participants |
| current guidelines to adjust treatment | Rate of Hypoglycemic Events | FAS analysis at V4 | 1 Participants |
| current guidelines to adjust treatment | Rate of Hypoglycemic Events | FAS analysis at V3 | 1 Participants |
| current guidelines to adjust treatment | Rate of Hypoglycemic Events | PPS analysis at V4 | 1 Participants |
| current guidelines to adjust treatment | Rate of Hypoglycemic Events | PPS analysis at V3 | 1 Participants |
Comparison: At Visit3 (FAS)p-value: >0.999Fisher Exact
Comparison: At Visit 4 (FAS)p-value: 0.6175Fisher Exact
Comparison: At Visit 3 (PPS)p-value: >0.999Fisher Exact
Comparison: At Visit4 (PPS)p-value: 0.5979Fisher Exact
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | The Achievement Rate of HbA1c (<6%) | FAS analysis | 13 Participants |
| GA guided anti-diabetic therapy adjustment | The Achievement Rate of HbA1c (<6%) | PPS analysis | 13 Participants |
| current guidelines to adjust treatment | The Achievement Rate of HbA1c (<6%) | FAS analysis | 8 Participants |
| current guidelines to adjust treatment | The Achievement Rate of HbA1c (<6%) | PPS analysis | 7 Participants |
Comparison: FAS Analysisp-value: 0.2199Chi-squared
Comparison: PPS analysisp-value: 0.0769Chi-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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GA guided anti-diabetic therapy adjustment | The Achievement Rate of HbA1c(<6.5%) | FAS analysis | 35 Participants |
| GA guided anti-diabetic therapy adjustment | The Achievement Rate of HbA1c(<6.5%) | PPS analysis | 32 Participants |
| current guidelines to adjust treatment | The Achievement Rate of HbA1c(<6.5%) | FAS analysis | 24 Participants |
| current guidelines to adjust treatment | The Achievement Rate of HbA1c(<6.5%) | PPS analysis | 23 Participants |
Comparison: FAS analysisp-value: 0.0649Chi-squared
Comparison: PPS analysisp-value: 0.0342Chi-squared