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

Sponsor
Yanbing Li
Study ID
NCT07173712
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: iGlarLixi group
  • Active Comparator: IDegAsp group
  • Active Comparator: iGlar group

Primary Outcome Measure

Proportion of subjects with optimal glycemic control [ Time Frame: 24 weeks ]

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