An interventional study of Nutren Diabetes and Fresubin Diabetes in Diabetes Mellitus, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 233 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of diabetes, and recent stable blood glucose control (refer to Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020) for the diagnosis of diabetes); Fasting blood glucose ≥ 7.0mmol/L or random blood glucose ≥ 11.1mmol/L (at least 2 consecutive tests); Blood glucose>7.8mmol/L (at least 3 consecutive tests, with at least 2 non same day results).
Exclusion Criteria:
Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day
Dietary Supplement: Nutren Diabetes
Product Replacement 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
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
24h AUC of Nutren Diabetes group with Fresubin Diabetes group
mean area under the blood glucose concentration-time curve from time 0 to 24h (24h AUC)
Time frame: 2-4 days since the start of formal intervention
Coefficient of variation of blood glucose
CV data from CGM
Time frame: Day 2 upon formal intervention
Time in range
TIR from CGM
Time frame: Day 2 - 4 upon formal intervention
Time above range
TAR from CGM
Time frame: Day 2 - 4 upon formal intervention
Time below range
TBR from CGM
Time frame: Day 2 - 4 upon formal intervention
Mean amplitude of glycemic excursion
MAGE from CGM
Time frame: Day 2 - 4 upon formal intervention
Peak blood glucose
Peak blood from CGM
Time frame: Day 4 upon formal intervention
Fasting plasma glucose
FPG from laboratory test
Time frame: Day 7 upon formal intervention
Prealbumin
Prealbumin from laboratory test
Time frame: Day 7 upon formal intervention
Albumin
Albumin from laboratory test
Time frame: Day 7 upon formal intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN)