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Effect of Henagliflozin on the Remission of Prediabetes Population: A National Multicenter, Randomized Controlled Study
This clinical trial evaluates the effectiveness of Henagliflozin combined with lifestyle interventions for managing patients with prediabetes. As global prediabetes rates rise, increasing the risk of diabetes and vascular issues, addressing treatment gaps is essential. Henagliflozin, a novel SGLT2 inhibitor developed in China, aims to improve glucose control and metabolic health when paired with lifestyle changes. The study's primary objectives include: assessing whether Henagliflozin can achieve normoglycemia in prediabetic patients after 6 months of treatment. The trial will compare three groups (Henagliflozin 5mg, 10mg, and a placebo), focusing on efficacy and safety. Participants, assigned randomly, will undergo a 6-month treatment phase and an 18-month follow-up. Regular health assessments will monitor glucose levels, metabolic health, and risks of major complications like cardiovascular events and microvascular diseases, with additional evaluations of C-peptide and insulin changes. Structured as a multicenter, randomized, double-blind, placebo-controlled study, it involves 984 prediabetic adults across 50 medical institutions in China. This comprehensive approach could redefine prediabetes management by integrating drug therapy with lifestyle modifications.
Details
| Lead sponsor | Shandong Provincial Hospital |
|---|---|
| Phase | Phase 4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 984 |
| Start date | 2024-06 |
| Completion | 2027-12 |
Conditions
- PreDiabetes
- Prediabetic State
- Type 2 Diabetes
- Glucose Metabolism Disorders
Interventions
- Henagliflozin 5mg
- Henagliflozin 10mg
- Placebo
Primary outcomes
- Normoglycemia Achievement Rates Post-6-Month Intervention — From 6 months post-intervention to 12 months
This measure assesses the proportion of participants who achieve normoglycemia from the end of a 6-month intervention until the 12-month assessment point. Normoglycemia is defined as fasting plasma glucose (FPG) less than 6.1 mmol/L and 2-hour post-prandial glucose (2h-PPG) less than 7.8 mmol/L. The measure includes rates of sustained remission (normal glycemic status lasting more than 6 months post-medication cessation), partial remission (lasting 3-6 months), and temporary remission (lasting less than 3 months).
Countries
China