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

Société des Produits Nestlé (SPN)1 site in 1 country233 target enrollmentFebruary 1, 2023

ConditionsDiabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 233
Locations: 1
Primary Endpoint: 24h AUC of Nutren Diabetes group with Fresubin Diabetes group
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 1, 2023

End Date

September 30, 2025

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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

•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;