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

Primary Purpose

Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nutren Diabetes
Fresubin Diabetes
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Male or female aged 18-75 years old (inclusive); 2. 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); 3. Glycosylated hemoglobin (HbA1c) <8.5%; 4. Inability to feed orally; 5. It is estimated that tube feeding would be required for more than 9 days; 6. 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: 1. 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; 2. 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; 3. Subjects with severe local broken skin which affects the use of continuous glucose monitoring (CGM) system; 4. 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; 5. Subjects with fasting C-peptide < 100 pmol/L (0.3 ng/mL); 6. Subjects who are receiving intracranial pressure reduction therapy; 7. Patients with active malignant tumor (except for glioma, meningioma) or in the period of radiochemotherapy; 8. 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; 9. Subjects with one of the following conditions: hemodynamic instability, life-threatening multiple injuries, as well as severe acidosis, shock, sepsis; 10. Recent (within 3 months) acute complications of diabetes, such as diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome; 11. It is expected to perform magnetic resonance imaging during the routine study; 12. Subjects who have used systemic glucocorticoid therapy within 2 weeks prior to screening or are expected to use during the study; 13. Women who are pregnant or plan to become pregnant or are breastfeeding; 14. Life expectancy ≤ 30 days; 15. Participated in other interventional clinical trials within 4 weeks prior to screening, including those involved in drugs, nutritional preparations, medical devices, etc.; 16. 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.

Sites / Locations

  • Peking Union Medical College hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nutren Diabetes group

Fresubin Diabetes group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Coefficient of variation of blood glucose
CV data from CGM
Time in range
TIR from CGM
Time above range
TAR from CGM
Time below range
TBR from CGM
Mean amplitude of glycemic excursion
MAGE from CGM
Peak blood glucose
Peak blood from CGM
Fasting plasma glucose
FPG from laboratory test
Prealbumin
Prealbumin from laboratory test
Albumin
Albumin from laboratory test

Full Information

First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
Nestle Health Science
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1. Study Identification

Unique Protocol Identification Number
NCT05859165
Brief Title
To Evaluate Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes)
Official Title
Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes) for Nutritional Support in Diabetic Patients With Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
Nestle Health Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 aound 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutren Diabetes group
Arm Type
Experimental
Arm Description
Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day
Arm Title
Fresubin Diabetes group
Arm Type
Active Comparator
Arm Description
Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutren Diabetes
Intervention Description
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Fresubin Diabetes
Intervention Description
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
Primary Outcome Measure Information:
Title
24h AUC of Nutren Diabetes group with Fresubin Diabetes group
Description
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 Outcome Measure Information:
Title
Coefficient of variation of blood glucose
Description
CV data from CGM
Time Frame
Day 2 upon formal intervention
Title
Time in range
Description
TIR from CGM
Time Frame
Day 2 - 4 upon formal intervention
Title
Time above range
Description
TAR from CGM
Time Frame
Day 2 - 4 upon formal intervention
Title
Time below range
Description
TBR from CGM
Time Frame
Day 2 - 4 upon formal intervention
Title
Mean amplitude of glycemic excursion
Description
MAGE from CGM
Time Frame
Day 2 - 4 upon formal intervention
Title
Peak blood glucose
Description
Peak blood from CGM
Time Frame
Day 4 upon formal intervention
Title
Fasting plasma glucose
Description
FPG from laboratory test
Time Frame
Day 7 upon formal intervention
Title
Prealbumin
Description
Prealbumin from laboratory test
Time Frame
Day 7 upon formal intervention
Title
Albumin
Description
Albumin from laboratory test
Time Frame
Day 7 upon formal intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Male or female aged 18-75 years old (inclusive); 2. 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); 3. Glycosylated hemoglobin (HbA1c) <8.5%; 4. Inability to feed orally; 5. It is estimated that tube feeding would be required for more than 9 days; 6. 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: 1. 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; 2. 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; 3. Subjects with severe local broken skin which affects the use of continuous glucose monitoring (CGM) system; 4. 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; 5. Subjects with fasting C-peptide < 100 pmol/L (0.3 ng/mL); 6. Subjects who are receiving intracranial pressure reduction therapy; 7. Patients with active malignant tumor (except for glioma, meningioma) or in the period of radiochemotherapy; 8. 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; 9. Subjects with one of the following conditions: hemodynamic instability, life-threatening multiple injuries, as well as severe acidosis, shock, sepsis; 10. Recent (within 3 months) acute complications of diabetes, such as diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome; 11. It is expected to perform magnetic resonance imaging during the routine study; 12. Subjects who have used systemic glucocorticoid therapy within 2 weeks prior to screening or are expected to use during the study; 13. Women who are pregnant or plan to become pregnant or are breastfeeding; 14. Life expectancy ≤ 30 days; 15. Participated in other interventional clinical trials within 4 weeks prior to screening, including those involved in drugs, nutritional preparations, medical devices, etc.; 16. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Wang
Phone
+86 10 84348448
Email
Vincent.wang2@cn.nestle.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Chen
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College hospital
City
Beijing
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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