Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia (Stardust)

A Randomized, Double-blind, Placebo- and Active-Controlled, Single-Center, Three-time-period, Crossover Study to Evaluate the Effects of Sprinkled Format REDUCOSE on Post-Prandial Glycemic Response in Asian Patients With Type 2 Diabetes

This is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format REDUCOSE compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Dietary Supplement
• Intervention / Treatment: Dietary supplement: Dietary Supplement: Sprinkled Format REDUCOSE.; Other: Reference control; Other: Active comparator

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529757
    • Temasek Polytechnic
• United States
  • California
    • Tustin, California, United States, 92780
      • Orange County Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willing and able to sign written informed consent prior to study entry.
• Participants who self-identify as Asian; male or female, >18 years of age.
• Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes).
• Treatment naïve or on active therapy with metformin at a daily dose of 500-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
• Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
• Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.

Exclusion Criteria:

• Fasting plasma glucose >220 mg/dl at screening.
• Impaired kidney function, eGFR of <60 mL/min/1.73 m2 at screening.
• BMI >35 kg/m2.
• Weight ≤ 50 kg.
• Elevated liver transaminase > 3 ULN at screening.
• Ongoing or recent (i.e. < 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin.
• Ongoing or recent (i.e. < 3 month) injectable insulin therapy.
• Ongoing or recent (i.e. < 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss >5% within previous 6 months.
• Ongoing or recent (i.e. < 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
• Major medical/surgical event requiring hospitalization in the last 3 months.
• Known allergy and intolerance to product components or paracetamol.
• Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
• Are unable to comply with protocol procedures in the opinion of the investigator.
• Have a hierarchical link with the research team members.
• Positive pregnancy test or breast-feeding at screening.
• Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
• Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ARM A: Sprinkled Format REDUCOSE; 2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate	Dietary supplement: Dietary Supplement: Sprinkled Format REDUCOSE.; 2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate
PLACEBO_COMPARATOR: ARM B: Placebo B: Standard Meal; A placebo matching to the test product will be used as control	Other: Reference control; A placebo matching to the test product will be used as control
PLACEBO_COMPARATOR: ARM C: Placebo C: Acarbose; Acarbose 100 mg tablet (provided in open-label format)	Other: Active comparator; Acarbose 100 mg tablet (provided in open-label format)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial glycemic excursion (ARMs A and B)	Incremental area under the curve post-prandial glycemic excursion (iAUC 0-1h, iAUC 0-2h, iAUC 0-3h).	0 ,15, 30, 60, 120, and 180 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2h post-prandial glucose levels (ARMs A and B)	Incremental area under the curve 2h post-prandial glucose levels	0 ,15, 30, 60, and 120 minutes.
Total glucose (All ARMS)	Total glucose AUC 0-1h (tAUC 0-1h, tAUC 0-2h, tAUC 0-3h)	0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose iCmax (ARMs A and B)	Plasma glucose iCmax	0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose Tmax (ARMs A and B)	Plasma glucose Tmax	0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose AUC (ARMs A and B)	protocol states (iAUC 0-3h, tAUC 0-3h)	0 ,15, 30, 60, 120, and 180 minutes.
Serum insulin (All ARMs)	Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h)	0 ,15, 30, 60, 120, and 180 minutes.
Plasma GLP-1 (ARMs A and B)	Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)	0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP (ARMs A and B)	Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)	0 ,15, 30, 60, 120, and 180 minutes.
Plasma interleukin-6 (ARMs A and B)	Plasma interleukin-6 (IL-6) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)	0 ,15, 30, 60, 120, and 180 minutes.
Gastric emptying (ARMs A and B)	Gastric emptying (iAUC 0-1h, tAUC 0-1h, iAUC 0-3h, tAUC 0-3h, Cmax and Tmax for paracetamol)	0 ,15, 30, 60, 120, and 180 minutes.
Matsuda Index (ARMs A and B)	Matsuda Index	0, 30, 60, and 120 minutes.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose timepoints (ARMs A and B)	Plasma glucose at individual timepoints	0 ,15, 30, 60, 120, and 180 minutes.
Serum insulin timepoints (ARMs A and B)	Serum insulin at individual timepoints	0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP and GLP-1 (ARMs A and B)	Plasma GIP and GLP-1 at individual timepoints	0 ,15, 30, 60, 120, and 180 minutes.
Plasma IL-6 (ARMs A and B)	Plasma IL-6 at individual timepoints	0 ,15, 30, 60, 120, and 180 minutes.
Plasma GLP-1 iAUC (ARMs A and B)	Plasma GLP-1 (iAUC 0-1h, tAUC 0-1h)	0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP iAUC (ARMs A and B)	Plasma GIP (iAUC 0-1h, tAUC 0-1h)	0 ,15, 30, 60, 120, and 180 minutes.
Plasma IL-6 iAUC (ARMs A and B)	Plasma IL-6 (iAUC 0-4h, tAUC 0-4h, iAUC 0-2h, tAUC 0-2h, iAUC 0-1h, tAUC 0-1h)	0 ,15, 30, 60, 120, and 180 minutes.

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2021
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (ACTUAL): May 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No