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

Nestlé

Status: Completed

Conditions: Dietary Supplement

Treatments: Dietary Supplement: Dietary Supplement: Sprinkled Format REDUCOSE.; Other: Active comparator; Other: Reference control

Study type: Interventional

Funder types: Industry

Identifiers

NCT04877366

2019CLI

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

ARM A: Sprinkled Format REDUCOSE

Active Comparator group

Description:

2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate

Treatment:

Dietary Supplement: Dietary Supplement: Sprinkled Format REDUCOSE.

ARM B: Placebo B: Standard Meal

Placebo Comparator group

Description:

A placebo matching to the test product will be used as control

Treatment:

Other: Reference control

ARM C: Placebo C: Acarbose

Placebo Comparator group

Description:

Acarbose 100 mg tablet (provided in open-label format)

Treatment:

Other: Active comparator