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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859165
• Other study ID #: 22.01.CN.NHS
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: Vincent Wang
• Phone: +86 10 84348448
• Email: Vincent.wang2[@]cn.nestle.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female aged 18-75 years old (inclusive);

• Diagnosis of diabetes, and stable use of hypoglycemic drugs for about 1 month (refer to Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020) for the diagnosis of diabetes);

• Glycosylated hemoglobin (HbA1c) <8.5%;

• 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;

• 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);

• Subjects who are receiving intracranial pressure reduction therapy;

• 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;

• It is expected to perform magnetic resonance imaging during the routine study;

• Subjects who have used systemic glucocorticoid therapy within 2 weeks prior to screening or are expected to use during the study;

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• Nutren Diabetes
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
• Fresubin Diabetes
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day

Locations

Country	Name	City	State
China	Peking Union Medical College hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	Nestle Health Science

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2-4 days since the start of formal intervention
Secondary	Coefficient of variation of blood glucose	CV data from CGM	Day 2 upon formal intervention
Secondary	Time in range	TIR from CGM	Day 2 - 4 upon formal intervention
Secondary	Time above range	TAR from CGM	Day 2 - 4 upon formal intervention
Secondary	Time below range	TBR from CGM	Day 2 - 4 upon formal intervention
Secondary	Mean amplitude of glycemic excursion	MAGE from CGM	Day 2 - 4 upon formal intervention
Secondary	Peak blood glucose	Peak blood from CGM	Day 4 upon formal intervention
Secondary	Fasting plasma glucose	FPG from laboratory test	Day 7 upon formal intervention
Secondary	Prealbumin	Prealbumin from laboratory test	Day 7 upon formal intervention
Secondary	Albumin	Albumin from laboratory test	Day 7 upon formal intervention