NCT07173712

Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes

Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Yanbing Li · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT. A total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine/lixisenatide, group B with insulin degludec/aspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study. Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C \<7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C \<6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	CSII	Short term intensive insulin therapy
DRUG	Insulin glargine /lixisenatide Fixed Ratio Combination	Insulin Glargine and Lixisenatide Injection(I) Treatment for 24 weeks
DRUG	Insulin Degludec and Insulin Aspart Injection	Insulin Degludec and Insulin Aspart Injection Treatment for 24 weeks
DRUG	Insulin Glargine (HOE901 - U300)	Insulin Glargine Treatment for 24 Weeks
DRUG	Metformin	Metformin Treatment for 24 weeks

Timeline

• Start date: 2026-03-15
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-09-15
• Last updated: 2026-02-06