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

NCT05227677 | Completed Results

• 1 other identifier: GAID1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; glycated albumin; intervention; anti-diabetic regimens; Hemoglobin A1c

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (15)

• The Achievement Rate of HbA1c(<6.5%)

  12 weeks

• The Achievement Rate of HbA1c (<6%)

  12 weeks

• Change in HbA1c Levels

  12 weeks

• Rate of Change in HbA1c Levels

  12 weeks

• Rate of Hypoglycemic Events

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

Study Arms (2)

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

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.

GA guided anti-diabetic therapy adjustment

current guidelines to adjust treatment OTHER

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.

current guidelines to adjust treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asahi Kasei Pharma Corporation: lead

Study Sites (7)

The third people's hospital of DATONG

Datong, Shanxi, China

Location

Beijing Haidian Hospital

Beijing, China

Location

Beijing Pinggu District Hospital

Beijing, China

Location

Beijing Shijingshan Hospital

Beijing, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Location

Civil Aviation General Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Related Publications (2)

• 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.

  PMID: 31771933 BACKGROUND

• 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.

  PMID: 27496253 BACKGROUND

Related Links

• Articles related to clinical trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Takuji Kohzuma
• Organization: Nagase Diagnostics Co.,Ltd.

takuji.kohzuma@nagase.co.jp

09080045463

Study Officials

• Linong Ji, Professor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: August 15, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)