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Effect of Ultra-short-term insulin therapy combined with once-weekly semaglutide in clinical remission in middle-aged and elderly patients with type 2 diabetes mellitus: an open-label, randomised controlled trial

Effect of Ultra-short-term insulin therapy combined with once-weekly semaglutide in clinical remission in middle-aged and elderly patients with type 2 diabetes mellitus: an open-label, randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059717
Enrollment
Unknown
Registered
2022-05-09
Start date
2022-05-05
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

Group 1 :Smeaglutide: 0.25 mg to 1.0 mg H QW
Group 2:Insulin glargine: Adjusted according to FBG, the maximum dose is less than or equal to 40 U/d

Sponsors

Jiangsu Province Official Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. T2DM patients who meet the diagnostic criteria of diabetes in 1999 by WHO; 2. Age 45-75 years old; 3. HbA1c 7.5-10.0% 4. The course of diabetes is less than 5 years; 5. Not taking hypoglycemic drugs or only taking metformin; 6. BMI 20-32.5 kg/m2 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Late-onset autoimmune diabetes or secondary diabetes in adults; 2. Acute complications of diabetes, severe chronic complications (proliferative retinopathy, diabetic nephropathy stage V); 3. Various types of anemia that affect HbA1c levels; 4. Fasting C-peptide < 1.2 ng/ml (1 ng/ml = 0.33 nmol/L); 5. Severe heart, liver and kidney diseases; 6. Those with uncontrolled severe infectious diseases; 7. Use of drugs that affect blood sugar, such as glucocorticoids, growth hormones, antipsychotics, etc.; 8. Have cognitive impairment and cannot cooperate with research and follow-up; 9. Combined with malignant tumors and other diseases, life expectancy < 5 years.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;2 hours postprandial blood glucose;Glycated hemoglobin, HbA1c;Proportion of discontinuing hypoglycemic drugs;Proportion of adding other hypoglycemic drugs;

Secondary

MeasureTime frame
Glucose below target range time, TBR;Time when glucose is above target range, TAR;Time glucose is in target range, TIR;islet ß-cell function;insulin sensitivity;The incidence of hypoglycemia;Body Mass Index, BMI;atherosclerotic heart disease, ASCVD;diabetic nephropathy, DKD;

Countries

China

Contacts

Public ContactTang Wei

Jiangsu Province Official Hospital

drtangwei@njmu.edu.cn+86 13813952636

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026