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Type 2 Diabetes MellitusNCT05227677

Value of Glycated Albumin in Intervention of Glycemic Control in Chinese Patients With Type 2 Diabetes

A study testing GA guided anti-diabetic therapy adjustment and current guidelines to adjust treatment in people with Type 2 Diabetes Mellitus, run by Asahi Kasei Therapeutics Corporation at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
GA guided anti-diabetic therapy adjustment and current guidelines to adjust treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
7 sitesChina
Study dates
15 Aug 2022to 31 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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).
Show all 11Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Haidian Hospital

    Beijing

  • Beijing Pinggu District Hospital

    Beijing

  • Beijing Shijingshan Hospital

    Beijing

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing

  • Civil Aviation General Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • The third people's hospital of DATONG

    Datong, Shanxi

Other trials in China

About this study

Official title: Value of Glycated Albumin in Intervention of Glycemic Control in Patients With Type 2 Diabetes: A Multicenter, Randomized Controlled Clinical Study

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.

Read the 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.

Being tested
GA guided anti-diabetic therapy adjustment, current guidelines to adjust treatment
Keywords
Type 2 diabetes mellitus, glycated albumin, intervention, anti-diabetic regimens, Hemoglobin A1c
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GA guided anti-diabetic therapy adjustmentOther

    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.

  • current guidelines to adjust treatmentOther

    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.

Study groups in NCT05227677
Study groupRoleWhat they receive
GA guided anti-diabetic therapy adjustmentExperimentalThe 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.
Receives: Other: GA guided anti-diabetic therapy adjustment
current guidelines to adjust treatmentActive comparatorThe 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.
Receives: Other: current guidelines to adjust treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Achievement Rate of HbA1c (<7%)

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

    Measured: 12 weeks

Secondary outcomes (15)

  1. 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.

    Measured: 12 weeks

  2. The Achievement Rate of HbA1c (<6%)

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

    Measured: 12 weeks

  3. Change in HbA1c Levels

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

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. Rate of Hypoglycemic Events

    To compare the rate of hypoglycemic events between the two groups

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

  6. Change in HOMA-β Levels

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

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

  9. 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.

    Measured: 12 weeks

  10. Change in Weight

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

    Measured: 12 weeks

  11. Percent Change in Weight

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

    Measured: 12weeks

  12. Change in Waist Circumferences

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

    Measured: 12 weeks

  13. Percent Change in Waist Circumferences

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

    Measured: 12 weeks

  14. Change in BMI

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

    Measured: 12 weeks

  15. Percent Change in BMI

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start15 Aug 2022
  3. Primary completion31 Aug 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05227677
Sponsor's protocol ID
GAID1
Status last verified
Nov 2025
First submitted
27 Jan 2022
Last updated
4 Dec 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31771933

  • Lu JM, Ji LN, 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, Pan RQ, Gao Y. Glycated albumin is superior to glycated hemoglobin for glycemic control assessment at an early stage of diabetes treatment: A multicenter, prospective study. J Diabetes Complications. 2016 Nov-Dec;30(8):1609-1613. doi: 10.1016/j.jdiacomp.2016.07.007. Epub 2016 Jul 16.

    PubMed 27496253

  • Ren Q, Zhang R, Huang W, Yang X, Xu J, Li Y, Lin S, Duan J, Yan H, Chen F, Wang Z, Liu H, Wang J, Chen X, Chen L, Gao Y, Zhang P, Ba T, Takuji K, Ji L. Glycated Albumin Guided Therapy in Newly Diagnosed Type 2 Diabetes A Randomized Controlled Trial. J Diabetes. 2026 Aug;18(8):e70263. doi: 10.1111/1753-0407.70263.

    PubMed 42608319

Questions about this trial

What is this clinical trial studying?

A study testing GA guided anti-diabetic therapy adjustment and current guidelines to adjust treatment in people with Type 2 Diabetes Mellitus, run by Asahi Kasei Therapeutics Corporation at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Achievement Rate of HbA1c (<7%) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05227677, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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