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

Last updated: November 21, 2025
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Completed

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Nutren Diabetes

Fresubin Diabetes

Clinical Study ID

NCT05859165
22.01.CN.NHS
  • Ages 18-90
  • All Genders

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.

Eligibility Criteria

Inclusion

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 thestudy procedures of this trial and are willing to sign the informed consent form (ICF).

Exclusion

Exclusion Criteria:

  • Subjects with congenital metabolism disorder or allergy to any ingredient in theproduct (such as whey protein, milk protein concentrate, soybean lecithin); thosewith congenital intolerance to fructose;

  • Patients who are not suitable for enteral nutrition, such as those with activegastrointestinal (GI) hemorrhage, intestinal ischemia, paralytic/mechanical ileus,decreased GI tension, stress ulcer, as well as severe abdominal distension, diarrheaand other digestive and absorptive dysfunction. If the above situation exists, butthe researchers believe that enteral nutrition is still applicable, screening can beconducted;

  • Subjects with severe local broken skin which affects the use of continuous glucosemonitoring (CGM) system;

  • Subjects who have concurrent severe malnutrition (body mass index [BMI] <15), severehypertriglyceridemia (triglyceride≥5.6 mmol/L), severe hypoproteinemia (albumin<20g/L), severe immunosuppression (neutrophils<1500/mm3 or lymphocytes<500/mm3), severeanemia (hemoglobin<60 g/L), severe infection, high fever and other stressconditions;;

  • Subjects with fasting C-peptide < 100 pmol/L (0.3 ng/mL);

  • Patients with active malignant tumor (except for glioma, meningioma) or in theperiod 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 < 30mL/min/1.73 m2, or levels of transaminases or transpeptidases more than 3 times theupper 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 diabeticketoacidosis, hyperosmolar hyperglycemic syndrome;

  • Subjects who have used systemic glucocorticoid therapy within 2 weeks prior toscreening or are expected to use during the study, If the screening requires the useof physiological replacement doses of glucocorticoids for other diseases prior toscreening, and the researcher evaluates that the glucocorticoid dose can remainstable 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 toscreening, including those involved in drugs, nutritional preparations, medicaldevices, etc.;

  • Other cases not eligible for this study in the investigator's opinion, such asinflammatory bowel disease (Crohn's disease or ulcerative colitis), acutepancreatitis, unstable vital signs, and if it does, the reasons for ineligibilityshould be recorded.

Study Design

Total Participants: 233
Treatment Group(s): 2
Primary Treatment: Nutren Diabetes
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Peking Union Medical College hospital

    Beijing,
    China

    Site Not Available

  • Peking Union Medical College hospital

    Beijing 1816670,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.