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Comparative study on the effect of subcutaneous injection of biphasic insulin aspart 30 with needle free syringe and insulin pen on insulin usage in patients with type 2 diabetes

Comparative study on the effect of subcutaneous injection of biphasic insulin aspart 30 with needle free syringe and insulin pen on insulin usage in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083658
Enrollment
Unknown
Registered
2024-04-29
Start date
2020-02-10
Completion date
Unknown
Last updated
2024-05-06

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:The first stage is needle free syringe injection, and the second stage is insulin pen injection
Group 2:The first stage is insulin pen injection, and the second stage is needle free syringe injection

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Men or women aged 18-75 and women of childbearing age should take sufficient contraceptive measures to minimize the risk of pregnancy; (2) Conform to the diagnostic criteria of type 2 diabetes and the course of disease is more than half a year; (3) 18 kg/m^2<=BMI<=30kg/m^2; (4)Patients who received 2-3 times premixed insulin analogues daily (excluding secretagogues); (5) Fasting venous blood glucose is between 5.0-9.0 mmol/L; Glycated hemoglobin (HbA1c) 6.0-10.0%; (6) Who have read and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Individuals who have a conflict of interest with this study; (2) Poor blood glucose control, unable to participate in this study, such as repeated hypoglycemia, diabetes ketoacidosis or hyperosmolar coma history and other adverse events of blood glucose control; (3) Serious complications of diabetes, such as diabetes foot, diabetes nephropathy, etc; (4) Serious cardiovascular and cerebrovascular events occurred within the past 6 months; (5) Application of hormones or immunosuppressants, for those with immunodeficiency or low immunity; (6) Application of non steroidal anti-inflammatory drugs; (7) Application of insulin secretagogues such as sulfonylureas; (8) Individuals with a history of tumors; (9) Have a history of unstable or rapidly progressing kidney disease; (10) History of psychiatric mental illness; (11) Hemoglobinopathy (such as sickle cell anemia, thalassemia, History of iron granulocyte anemia etc.); (12) Pregnant or lactating women; (13) There have been clear infections recently, such as urinary tract infections and pneumonia; (14) Recent active bleeding of important organs, such as gastric bleeding, cerebral hemorrhage, etc; (15) Skin diseases such as exfoliative dermatitis, pustules, and pyogenic infections; (16) Have a history of acute pancreatitis or pancreatic resection; (17) Researchers believe that it may result in subjects being unable to complete this study or any situation that can pose significant risks to the subjects. (18) The laboratory test results are as follows: a. Significant liver dysfunction or active liver disease (AST>3.0 times normal upper limit or ALT>3.0 times normal upper limit); b. eGFR<60ml/min; c. Anemia caused by any cause; d. The pregnancy test results for women of childbearing age are positive.

Design outcomes

Primary

MeasureTime frame
Fasting venous blood glucose;HbA1c;Fingertip blood glucose monitoring record;

Secondary

MeasureTime frame
Continuous glucose monitoring;

Countries

China

Contacts

Public ContactJianling Du

The First Affiliated Hospital of Dalian Medical University

dujianling63@163.com+86 180 9887 5599

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026