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

January 19, 2024 updated by: Asahi Kasei Pharma Corporation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Linong Ji
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
          • Jian Xu
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Haidian Hospital
        • Contact:
        • Contact:
          • Wei Huang
      • Beijing, China
        • Recruiting
        • Beijing Pinggu District Hospital
        • Contact:
          • Yufeng Li
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Shijingshan Hospital
        • Contact:
          • Shanshan Lin
        • Contact:
      • Beijing, China
        • Active, not recruiting
        • Civil Aviation General Hospital
    • Shanxi
      • Datong, Shanxi, China
        • Recruiting
        • The Third People's Hospital of Datong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GA guided anti-diabetic therapy adjustment
The GA concentration 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
The GA concentration 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.
Active Comparator: current guidelines to adjust treatment
The GA concentration 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
The GA concentration 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The achievement rate of HbA1c (≤7%)
Time Frame: 12 weeks
To compare the achievement rate of HbA1c(≤7%) between the two groups at 12-week of follow-up.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The achievement rate of HbA1c(≤6.5%)
Time Frame: 12 weeks
To compare the achievement rate of HbA1c(≤6.5%) between the two groups at 12-week of follow-up.
12 weeks
The extent of change of HbA1c
Time Frame: 12 weeks
To compare the extent of change of HbA1c between the two groups at 12-week of follow-up.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asahi Kasei Pharma Corporation

Investigators

  • Principal Investigator: Linong Ji, Professor, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAID1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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