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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
30
2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate
A placebo matching to the test product will be used as control
Acarbose 100 mg tablet (provided in open-label format)
Orange County Research Center
Tustin, California, United States
Temasek Polytechnic
Singapore, Singapore
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).
Time frame: 0 ,15, 30, 60, 120, and 180 minutes.
2h post-prandial glucose levels (ARMs A and B)
Incremental area under the curve 2h post-prandial glucose levels
Time frame: 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)
Time frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose iCmax (ARMs A and B)
Plasma glucose iCmax
Time frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose Tmax (ARMs A and B)
Plasma glucose Tmax
Time frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose AUC (ARMs A and B)
protocol states (iAUC 0-3h, tAUC 0-3h)
Time frame: 0 ,15, 30, 60, 120, and 180 minutes.
Serum insulin (All ARMs)
Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h)
Time frame: 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)
Time frame: 0 ,15, 30, 60, 120, and 180 minutes.
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Plasma GIP (ARMs A and B)
Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
Time frame: 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)
Time frame: 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)
Time frame: 0 ,15, 30, 60, 120, and 180 minutes.
Matsuda Index (ARMs A and B)
Matsuda Index
Time frame: 0, 30, 60, and 120 minutes.