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

What this study is testing ClinicalTrials.gov NCT07173712 ↗

Description as written by the study sponsor.

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.

Treatments tested

• CSII Drug

  Short term intensive insulin therapy

• Insulin glargine /lixisenatide Fixed Ratio Combination Drug

  Insulin Glargine and Lixisenatide Injection(I) Treatment for 24 weeks

• Insulin Degludec and Insulin Aspart Injection Drug

  Insulin Degludec and Insulin Aspart Injection Treatment for 24 weeks

• Insulin Glargine (HOE901 - U300) Drug

  Insulin Glargine Treatment for 24 Weeks

• Metformin Drug

  Metformin Treatment for 24 weeks