N/A
Completed N=200
Value of Glycated Albumin in Intervention of Glycemic Control in Chinese Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT05227677 ↗Enrolled (actual)
200
Serious AEs
1.0%
Results posted
Dec 2025
Primary outcomePrimary: The Achievement Rate of HbA1c (<7%) — 63; 65; 58; 64 Participants — p=0.9917
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Achievement Rate of HbA1c (<7%) |
63; 65; 58; 64 | 0.9917 |
| SECONDARY The Achievement Rate of HbA1c(<6.5%) |
35; 24; 32; 23 | 0.0649 |
| SECONDARY The Achievement Rate of HbA1c (<6%) |
13; 8; 13; 7 | 0.2199 |
| SECONDARY Change in HbA1c Levels |
-2.3; -1.7; -2.3; -1.7 | 0.0200 sig |
| SECONDARY Rate of Change in HbA1c Levels |
-24.794; -21.574; -24.971; -21.474 | 0.0256 sig |
| SECONDARY Rate of Hypoglycemic Events |
1; 1; 2; 1; 1; 1 | >0.999 |
| SECONDARY Change in HOMA-β Levels |
33.60; 21.50; 33.70; 21.50 | 0.0404 sig |
| SECONDARY Percent Change in HOMA-β Levels |
89.10; 66.30; 90.30; 66.30 | 0.0408 sig |
| SECONDARY Change in HOMA-IR Levels |
-2.10; -1.10; -2.30; -1.10 | 0.0303 sig |
| SECONDARY Percent Change in HOMA-IR Levels |
-42.35; -27.50; -43.80; -30.00 | 0.0374 sig |
| SECONDARY Change in Weight |
-2.45; -1.50; -2.40; -1.50 | 0.0086 sig |
| SECONDARY Percent Change in Weight |
-2.940; -1.670; -2.930; -1.830 | 0.0118 sig |
| SECONDARY Change in Waist Circumferences |
-4.00; -2.00; -4.00; -2.00 | 0.0057 sig |
| SECONDARY Percent Change in Waist Circumferences |
-4.00; -2.020; -3.960; -2.170 | 0.0065 sig |
| SECONDARY Change in BMI |
-0.85; -0.50; -0.80; -0.50 | 0.0087 sig |
| SECONDARY Percent Change in BMI |
-3.140; -1.790; -3.000; -1.820 | 0.0103 sig |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT05227677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.