Health TrialsbyHealthPanel

Henagliflozin's Impact on Prediabetes Remission

ConditionsPreDiabetesPrediabetic StateType 2 DiabetesGlucose Metabolism Disorders
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShandong Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects between the ages of 18 and 65 years;

Individuals without hypoglycemic therapy before, including hypoglycemic drugs or traditional Chinese medicine formulations with hypoglycemic effects;

Prediabetic patients as defined by Expert Consensus on Intervention for Prediabetes in Chinese Adults, 2023 Edition:1)Fasting plasma glucose (FPG) between 6.1 and 7.0 mmol/L and/or 2-hour postprandial glucose (2h-PPG) between 7.8 and 11.1 mmol/L; 2)And/or HbA1c between 5.7% and 6.5%;

Individuals willing to provide written informed consent and can comply with study procedures and follow-up.

Disqualifiers

Allergic to Henagliflozin;

Previously diagnosed with diabetes;

HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol/L or PPG ≥ 11.1 mmol/L;

Use of GLP-1 receptor agonists, orlistat, or other weight-reducing drugs in the past 3 months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Henagliflozin 5mg

    Drug

    Henagliflozin 5mg + lifestyle intervention

  • Henagliflozin 10mg

    Drug

    Henagliflozin 10mg+ lifestyle intervention

  • Placebo

    Drug

    Placebo+ lifestyle intervention

Treatment groups

984 Participants
are divided into 3 treatment groups
Group A: Henagliflozin5mg + lifestyle interventionExperimental treatment 1 intervention
Group B: Henagliflozin10mg+ lifestyle interventionExperimental treatment 1 intervention
Group C: placebo+ lifestyle interventionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Normoglycemia Achievement Rates Post-6-Month Intervention

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).

Time frame
From 6 months post-intervention to 12 months

Secondary outcomes

1

Blood Glucose Control Normalization

Proportion and duration of normalization of blood glucose levels within 24 months in the three study groups.

Time frame
From 6 months post-intervention to 24 months
2

Incidence of New-Onset Type 2 Diabetes

Incidence of new-onset type 2 diabetes within 24 months in the three study groups.

Time frame
From 0 to 24 months
3

Changes in HbA1c Levels

Changes in HbA1c levels over the 24-month period in the three study groups.

Time frame
From 0 to 24 months
4

Impact of Glycemic Status at 12 Months

Impact of glycemic status at 12 months on subsequent reversal to normoglycemia and risk of new-onset type 2 diabetes during the 12-24 month follow-up period in the three study groups.

Time frame
From 12 months to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: