Dietary Supplement
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDietary 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
OTHERReference control
A placebo matching to the test product will be used as control
OTHERActive comparator
Acarbose 100 mg tablet (provided in open-label format)
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-prandial glycemic excursion (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Incremental area under the curve post-prandial glycemic excursion (iAUC 0-1h, iAUC 0-2h, iAUC 0-3h). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose iCmax (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma glucose iCmax |
| Plasma glucose AUC (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | protocol states (iAUC 0-3h, tAUC 0-3h) |
| Serum insulin (All ARMs) | 0 ,15, 30, 60, 120, and 180 minutes. | Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h) |
| Plasma GLP-1 (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) |
| Plasma GIP (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) |
| Plasma interleukin-6 (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma interleukin-6 (IL-6) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) |
| Gastric emptying (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Gastric emptying (iAUC 0-1h, tAUC 0-1h, iAUC 0-3h, tAUC 0-3h, Cmax and Tmax for paracetamol) |
| Matsuda Index (ARMs A and B) | 0, 30, 60, and 120 minutes. | Matsuda Index |
| 2h post-prandial glucose levels (ARMs A and B) | 0 ,15, 30, 60, and 120 minutes. | Incremental area under the curve 2h post-prandial glucose levels |
| Total glucose (All ARMS) | 0 ,15, 30, 60, 120, and 180 minutes. | Total glucose AUC 0-1h (tAUC 0-1h, tAUC 0-2h, tAUC 0-3h) |
| Plasma glucose Tmax (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma glucose Tmax |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma GIP and GLP-1 (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma GIP and GLP-1 at individual timepoints |
| Plasma IL-6 (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma IL-6 at individual timepoints |
| Plasma GLP-1 iAUC (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma GLP-1 (iAUC 0-1h, tAUC 0-1h) |
| Plasma GIP iAUC (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma GIP (iAUC 0-1h, tAUC 0-1h) |
| Plasma IL-6 iAUC (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma IL-6 (iAUC 0-4h, tAUC 0-4h, iAUC 0-2h, tAUC 0-2h, iAUC 0-1h, tAUC 0-1h) |
| Plasma glucose timepoints (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Plasma glucose at individual timepoints |
| Serum insulin timepoints (ARMs A and B) | 0 ,15, 30, 60, 120, and 180 minutes. | Serum insulin at individual timepoints |
Countries
Singapore, United States
Outcome results
None listed