Status:
COMPLETED
Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Dietary Supplement
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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-b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04877366
Start Date
July 21 2021
End Date
December 1 2021
Last Update
October 15 2024
Active Locations (2)
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1
Orange County Research Center
Tustin, California, United States, 92780
2
Temasek Polytechnic
Singapore, Singapore, 529757