NCT05859165

To Evaluate Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes)

Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes) for Nutritional Support in Diabetic Patients With Dysphagia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study has a parallel, non-inferiority design, comparing the 24h AUC of Nutren Diabetes group with Fresubin Diabetes group at 2-4 days since the start of formal intervention.

Detailed description

This is a randomized, active-control, open labelled study in which either Nutren Diabetes or Fresubin Diabetes will be given to patients with diabetes for around 9 days. 24h AUC, TIR, TBR, prealbumin albumin etc. will be evaluated. And also safety-related laboratory parameters, numbers, severity, outcome of AEs will be evaluated too.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutren Diabetes	Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
DIETARY_SUPPLEMENT	Fresubin Diabetes	Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-03-18
• Completion: 2025-09-30
• First posted: 2023-05-15
• Last updated: 2025-11-24

Locations

1 site across 1 country: China