Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients

What Was Tested

This registered not phased trial tested Insulin Aspart.

It had two arms (groups): Continuous Beinaglutide infusion (experimental) and Continuouns Insulin aspart infusion (active comparator).

8-week Beinaglutide (continuous subcutaneous infusion) treatment group.

8-week insulin aspart (CSII) treatment group.

The registry classes the interventions as drug.

More on the Plan

Based on the dual roles of glucagon-like peptide 1 (GLP-1) in regulating fasting blood glucose and postprandial blood glucose secretion, the researchers adopted a combinational therapeutic model and will administer drug treatments during meals.

Newly diagnosed type 2 diabetic patients will be administered continuous subcutaneous Beinaglutide injections using a pump device.

This is a national-level, multicenter, randomized, open study with parallel controls.

The study consists of two phases: a 8-week treatment phase and a 12-week post-treatment follow-up period.

Who Took Part

The registry lists 115 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 to 70 years (inclusive) at enrollment, regardless of gender. Voluntary signing of the informed consent form. Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year. BMI between 24 kg/m² and 42 kg/m².

The full record lists 7 inclusion and 20 exclusion criteria; among the exclusions: patients with type 1 diabetes or other types of diabetes; history of pancreatitis; family history of medullary thyroid carcinoma.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-07-02 with completion listed for 2025-09.

It ran at 16 sites in China (16).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 29 secondary outcomes, for example Changes in fasting blood glucose from baseline after 8 weeks of treatment, Changes in postprandial blood glucose from baseline after 8 weeks of treatment, Changes in HbA1C from baseline after 8 weeks of treatment, Changes in weight from baseline after 8 weeks of treatment, Changes in waist circumference from baseline after 8 weeks of treatment and Changes in waist-to-hip ratio from baseline after 8 weeks of treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 115 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.