Clinical trial NCT04877366: Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplement
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.


Eligibility criteria: 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.

Primary outcomes:
measure: Post-prandial glycemic excursion (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
Secondary outcomes:
measure: 2h post-prandial glucose levels (ARMs A and B)
timeFrame: 0 ,15, 30, 60, and 120 minutes.
measure: Total glucose (All ARMS)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma glucose iCmax (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma glucose Tmax (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma glucose AUC (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Serum insulin (All ARMs)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma GLP-1 (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma GIP (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma interleukin-6 (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Gastric emptying (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Matsuda Index (ARMs A and B)
timeFrame: 0, 30, 60, and 120 minutes.
Other outcomes:
measure: Plasma glucose timepoints (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Serum insulin timepoints (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma GIP and GLP-1 (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma IL-6 (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma GLP-1 iAUC (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma GIP iAUC (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
measure: Plasma IL-6 iAUC (ARMs A and B)
timeFrame: 0 ,15, 30, 60, 120, and 180 minutes.
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Singapore
country: Singapore
facility: Temasek Polytechnic
Study officials:
References: