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CompletedNCT05859165Updated Nov 24, 2025

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

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

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2023, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
233
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female aged 18-90 years old (inclusive);
  • The subjects' blood glucose related indicators meet any of the following conditions:

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).

  • Glycosylated hemoglobin (HbA1c) \<10.0%;
  • Inability to feed orally;
  • It is estimated that tube feeding would be required for more than 9 days;
  • Patients or their guardians (or authorized personnel) have fully understood the study procedures of this trial and are willing to sign the informed consent form (ICF).

Exclusion criteria

Exclusion Criteria:

  • Subjects with congenital metabolism disorder or allergy to any ingredient in the product (such as whey protein, milk protein concentrate, soybean lecithin); those with congenital intolerance to fructose;
  • Patients who are not suitable for enteral nutrition, such as those with active gastrointestinal (GI) hemorrhage, intestinal ischemia, paralytic/mechanical ileus, decreased GI tension, stress ulcer, as well as severe abdominal distension, diarrhea and other digestive and absorptive dysfunction. If the above situation exists, but the researchers believe that enteral nutrition is still applicable, screening can be conducted;
  • Subjects with severe local broken skin which affects the use of continuous glucose monitoring (CGM) system;
  • Subjects who have concurrent severe malnutrition (body mass index [BMI] \<15), severe hypertriglyceridemia (triglyceride≥5.6 mmol/L), severe hypoproteinemia (albumin\<20 g/L), severe immunosuppression (neutrophils\<1500/mm3 or lymphocytes\<500/mm3), severe anemia (hemoglobin\<60 g/L), severe infection, high fever and other stress conditions;;
  • Subjects with fasting C-peptide \< 100 pmol/L (0.3 ng/mL);
  • Patients with active malignant tumor (except for glioma, meningioma) or in the period of radiochemotherapy;
  • Patients with severe cardiac failure (New York Heart Association [NYHA] Class IV); those with severe liver or renal impaired function (glomerular filtration rate \< 30 mL/min/1.73 m2, or levels of transaminases or transpeptidases more than 3 times the upper limit of normal); or those with conditions such as active hyperthyroidism, treatment-resistant hypothyroidism;
  • Subjects with one of the following conditions: hemodynamic instability, life-threatening multiple injuries, as well as severe acidosis, shock, sepsis;
  • Recent (within 3 months) acute complications of diabetes, such as diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome;
  • Subjects who have used systemic glucocorticoid therapy within 2 weeks prior to screening or are expected to use during the study, If the screening requires the use of physiological replacement doses of glucocorticoids for other diseases prior to screening, and the researcher evaluates that the glucocorticoid dose can remain stable during the study period, the subjects can be screened;
  • Women who are pregnant or plan to become pregnant or are breastfeeding;
  • Life expectancy ≤ 30 days;
  • Participated in other interventional clinical trials within 4 weeks prior to screening, including those involved in drugs, nutritional preparations, medical devices, etc.;
  • Other cases not eligible for this study in the investigator's opinion, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), acute pancreatitis, unstable vital signs, and if it does, the reasons for ineligibility should be recorded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
233 participants (actual)

Study arms

  • Experimental
    Nutren Diabetes group

    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

  • Active comparator
    Fresubin Diabetes group

    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

Interventions

  • Dietary supplementNutren Diabetes

    Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day

  • Dietary supplementFresubin Diabetes

    Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Coefficient of variation of blood glucose

    CV data from CGM

    Time frame: Day 2 upon formal intervention

  2. Time in range

    TIR from CGM

    Time frame: Day 2 - 4 upon formal intervention

  3. Time above range

    TAR from CGM

    Time frame: Day 2 - 4 upon formal intervention

  4. Time below range

    TBR from CGM

    Time frame: Day 2 - 4 upon formal intervention

  5. Mean amplitude of glycemic excursion

    MAGE from CGM

    Time frame: Day 2 - 4 upon formal intervention

  6. Peak blood glucose

    Peak blood from CGM

    Time frame: Day 4 upon formal intervention

  7. Fasting plasma glucose

    FPG from laboratory test

    Time frame: Day 7 upon formal intervention

  8. Prealbumin

    Prealbumin from laboratory test

    Time frame: Day 7 upon formal intervention

  9. Albumin

    Albumin from laboratory test

    Time frame: Day 7 upon formal intervention

07

Study locations

1 site
  • Peking Union Medical College hospital
    Beijing, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05859165
Lead sponsor
Société des Produits Nestlé (SPN)
Collaborators
Nestle Health Science
Responsible party
Sponsor
First posted
May 15, 2023
Start date
Feb 1, 2023
Primary completion
Mar 18, 2025
Completion
Sep 30, 2025
Last update
Nov 24, 2025

Study contacts

Wei Chen
principal investigator · Peking Union Medical College Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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