Trial · Interventional
Not yet recruitingPhase 4Registry dataRegimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 324 participants (estimated)
- Sponsor
- Yanbing Li · Other
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- 15 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Sept 2025
- Last update posted
- 6 Feb 2026
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
NCT07173712est. 15 Mar 2026 to est. 31 Dec 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- CSIIDrug
- Insulin glargine /lixisenatide Fixed Ratio CombinationDrug
- Insulin Degludec and Insulin Aspart InjectionDrug
- Insulin Glargine (HOE901 - U300)Drug
- MetforminDrug
Arms3
Active comparator
iGlarLixi group
Active comparator
IDegAsp group
Active comparator
iGlar group
Primary outcomes1
Outcomes the sponsor listed as primary.
Proportion of subjects with optimal glycemic control
Time frame · 24 weeks
Registry description
proportion of patients achieving glycosylated hemoglobin A1C \<7% at 24 weeks in each treatment group.
Secondary outcomes(4)
Proportion of subjects with excellent glycemic control
Time frame · 24 weeks
Registry description
proportion of patients achieving glycosylated hemoglobin A1C \<6.5% at 24 weeks in each treatment group.
Proportion of subjects with glycemic control
Time frame · 48 weeks
Registry description
proportion of patients achieving glycosylated hemoglobin A1C \<7% and \<6.5% at 48 weeks in each treatment group.
Medication Compliance
Time frame · 48 weeks
Registry description
differences in proportion of patients continuing the assigned regimen at 48 weeks in each treatment group.
Incidence of adverse events
Time frame · 24 weeks and 48 weeks
Registry description
differences in incident of weight gain, hypoglycemic events among treatment groups at 24 weeks and extension follow-up period.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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