NCT05227677Completed
Value of Glycated Albumin in Intervention of Glycemic Control in Chinese Patients With Type 2 Diabetes
Value of Glycated Albumin in Intervention of Glycemic Control in Patients With Type 2 Diabetes: A Multicenter, Randomized Controlled Clinical Study
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 27 Jan 2022
- Start date
- 15 Aug 2022
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Diseases
- Type 2 diabetes
- NCT number
- NCT05227677
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 15 Aug 2022 to the primary completion date, 31 Aug 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Systemic corticosteroids treatment in recent 1 month prior to screening (exception of inhalation or local external treatment).
- 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.
Lab values
- 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.
- 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.
Other
- Uncontrolled thyroid dysfunction.
- Pregnancy or lactating.
- Patients considered unsuitable for observation by investigators.
Who the study is looking for
- 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%
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Shijingshan Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Civil Aviation General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Pinggu District Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Haidian Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Third People's Hospital of Datong Coordinator of this site? Confirm its status | Datong | China | Unknown status |
Related publications
- Glycated Albumin Guided Therapy in Newly Diagnosed Type 2 Diabetes A Randomized Controlled Trial.J Diabetes · 2026 · PMID 42608319
This page is information, not medical advice. Discuss any trial with your doctor.