Efficacy and Safety Of Different Regimens In Patients With Type 2 Diabetes Receiving Intensive Insulin Therapy
NCT05545800 · Unknown status
Last updated 2026-05-28This clinical trial is testing different insulin treatment plans in adults with type 2 diabetes to see how they affect blood sugar control over time.
What this study is testing ClinicalTrials.gov NCT05545800 ↗
Description as written by the study sponsor.
The purpose of this studay is to compare the efficacy of different hypoglycemic regimens versus twice-daily premixed insulin in type 2 diabetes mellitus (T2DM) patients after short-term ntensive Insulin Therapy by using continuous glucose monitoring.
Treatments tested
- metformin+empagliflozin+insulin glargine Drug
Randomization was performed with the use of a computer-generated system provided by the sponsor. The dose of metformin will be initiated at 0.5 grams three times a day (the maximum dose is 2g/day); the dose of empagliflozin will be 10 milligrams once a day; insulin glargine will be received once daily at bedtime and the dose will be initiated at the 50% of 0.4-0.5 units/kg/day. All groups received counseling on lifestyle modification.
- IDegLira Drug
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients will be initiated on 16 units (16 units degludec/0.58 mg liraglutide) and titrated twice weekly. The maximum dose of IDegLira was 50 units (50 units degludec/1.8 mg liraglutide). All groups received counseling on lifestyle modification.
- premixed insulin analogues Drug
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients will received twice a day. The total daily insulin dose will be initiated at 0.4-0.5 units/kg/day and adjusted according to the plasma glucose. All groups received counseling on lifestyle modification.
| Main thing measured | Mean Change From Baseline in HbA1c |
|---|---|
| Sponsor | Xiangya Hospital of Central South University |
| Conditions studied | Type 2 Diabetes Mellitus |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05545800 ↗