Diabetes MellitusNCT05859165
To Evaluate Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes)
A study testing Nutren Diabetes and Fresubin Diabetes in people with Diabetes Mellitus, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Nutren Diabetes and Fresubin Diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes) for Nutritional Support in Diabetic Patients With Dysphagia
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Nutren Diabetes, Fresubin Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutren DiabetesDietary supplement
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
Fresubin DiabetesDietary supplement
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Nutren Diabetes group | Experimental | Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day Receives: Dietary Supplement: Nutren Diabetes |
| Fresubin Diabetes group | Active comparator | Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day Receives: Dietary Supplement: Fresubin Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2-4 days since the start of formal intervention
Secondary outcomes (9)
Coefficient of variation of blood glucose
CV data from CGM
Measured: Day 2 upon formal intervention
Time in range
TIR from CGM
Measured: Day 2 - 4 upon formal intervention
Time above range
TAR from CGM
Measured: Day 2 - 4 upon formal intervention
Time below range
TBR from CGM
Measured: Day 2 - 4 upon formal intervention
Mean amplitude of glycemic excursion
MAGE from CGM
Measured: Day 2 - 4 upon formal intervention
Peak blood glucose
Peak blood from CGM
Measured: Day 4 upon formal intervention
Fasting plasma glucose
FPG from laboratory test
Measured: Day 7 upon formal intervention
Prealbumin
Prealbumin from laboratory test
Measured: Day 7 upon formal intervention
Albumin
Albumin from laboratory test
Measured: Day 7 upon formal intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Feb 2023
- Primary completion18 Mar 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nestle Health Science
- Responsible party
- Sponsor
- Investigators
- Wei Chen, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859165
- Sponsor's protocol ID
- 22.01.CN.NHS
- Status last verified
- Nov 2025
- First submitted
- 4 May 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes) for Nutritional Support in Diabetic Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT05859165
- Acronym / sponsor ID
- 22.01.CN.NHS
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Nestle Health Science
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutren Diabetes group | Experimental | Dietary Supplement: Nutren DiabetesProduct Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day |
| Fresubin Diabetes group | Active comparator | Dietary Supplement: Fresubin DiabetesProduct Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutren DiabetesProduct replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day | Dietary supplement | Nutren Diabetes group |
| Fresubin DiabetesProduct replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day | Dietary supplement | Fresubin Diabetes group |
Primary outcome
24h AUC of Nutren Diabetes group with Fresubin Diabetes group
Time frame: 2-4 days since the start of formal intervention
mean area under the blood glucose concentration-time curve from time 0 to 24h (24h AUC)
9 secondary outcomes
Coefficient of variation of blood glucose
Time frame: Day 2 upon formal intervention
Time in range
Time frame: Day 2 - 4 upon formal intervention
Time above range
Time frame: Day 2 - 4 upon formal intervention
Time below range
Time frame: Day 2 - 4 upon formal intervention
Mean amplitude of glycemic excursion
Time frame: Day 2 - 4 upon formal intervention
Peak blood glucose
Time frame: Day 4 upon formal intervention
Fasting plasma glucose
Time frame: Day 7 upon formal intervention
Prealbumin
Time frame: Day 7 upon formal intervention
Albumin
Time frame: Day 7 upon formal intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Chen principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutren Diabetes and Fresubin Diabetes in people with Diabetes Mellitus, run by Société des Produits Nestlé (SPN) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h AUC of Nutren Diabetes group with Fresubin Diabetes group (time frame: 2-4 days since the start of formal intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.