Randomized, double-blind, placebo-controlled, clinical study on the effect of Diabetinol^® on glycemic control of subjects with impaired fasting glucose

Figures & data

Table 1 Baseline characteristics of study participants that completed the 24-week study

Baseline characteristics	Diabetinol^® (N=15)	Placebo (N=19)	P-valuea
	Mean ± (SD)	Mean ± (SD)
Age (years)	58.5±13.0	57.7±7.7	0.84
Sex			1.00b
Male	7 (46.7%)	10 (52.6%)
Female	8 (53.3%)	9 (47.4%)
On diabetic medication	12 (80.0%)	14 (73.7%)	1.00b
Height (m)	1.7±0.1	1.7±0.1	0.98
Weight (kg)	99.3±30.6	99.7±12.0	0.96
BMI (kg/m^2)	34.5±7.8	35.1±4.4	0.77
Waist circumference (cm)	109.2±16.7	111.0±9.7	0.52
Hip circumference (cm)	117.5±16.0	118.1±10.3	0.83
Waist-to-hip ratio	0.93±0.09	0.94±0.08	0.73
HbA1c (%)	7.03±0.80	7.06±1.49	0.93
Fasting blood glucose (mg/dL)	152±18	143±46	0.50
Fasting blood insulin (μIU/mL)	14.5±10.8	16.1±18.0	0.91
2-hour PP glucose (mg/dL)	311±70	297±94	0.62
Triglycerides (mg/dL)	181±125	167±88	0.70
Total cholesterol (mg/dL)	182±42	183±50	0.98
HDL-C (mg/dL)	38.7±9.6	40.8±13.0	0.60
LDL-C (mg/dL)	112±28	114±37	0.84

Notes:

a Statistical comparisons were performed using analysis of variance (ANOVA);

b statistical comparisons were performed using Fisher’s exact test.

Abbreviations: BMI, body mass index; HbA_1c, hemoglobin A_1c; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; PP, postprandial; SD, standard deviation.

Figure 1 Disposition of participants in this study.

Notes: *The adverse events in the Diabetinol^® group were diarrhea (n=3), elevated liver enzymes (n=1), and gastric complications (n=1). In the placebo group, one subject withdrew due to diarrhea. Two cases of diarrhea were assessed by the principal investigator as having a possible or probable relationship to the investigational product.
Abbreviations: ITT, intent-to-treat; PI, principal investigator.

Table 2 Glycemic parameters of study participants that completed the 24-week study

Glycemic Parameters	Diabetinol^® (N=15)	Placebo (N=19)	P-valuea
	Mean ± (SD)	Mean ± (SD)
FBG (mg/dL)
Baseline	152±18	143±46	–
Week 12	153±37	167±69	0.235
Week 24	159±54	166±69	0.462
Insulin (mg/dL)
Baseline	14.5±10.8	15.6±18.1	–
Week 12	19.1±17.8	14.5±12.9	0.097
Week 24	16.7±15.7	14.3±14.5	0.417
HbA1c (%)
Baseline	7.03±0.80	7.06±1.49	–
Week 12	6.95±0.86	6.90±1.57	0.724
Week 24	7.65±1.28	7.46±2.09	0.598
2-hour PP glucose (mg/dL)
Baseline	311±70	297±94	–
Week 12	330±86	330±102	0.543
Week 24	329±102	326±104	0.633

Notes:

a Statistical comparisons were performed using analysis of covariance (ANCOVA) adjusting for baseline values.

Abbreviations: SD, standard deviation; FBG, fasting blood glucose; HbA_1c, hemoglobin A_1c; PP, postprandial.

Figure 2 Four-hour postprandial serum glucose and insulin levels after supplementation with placebo or Diabetinol^®.

Note: The mean (± SD) 4-hour postprandial serum glucose (A and B) and insulin levels (C and D) in participants at baseline (diamonds, straight line) and after 12 (squares, hatched line) and 24 weeks (triangles, dotted line) of supplementation with placebo (A and C) or Diabetinol^® (B and D).
Abbreviations: min, minutes; SD, standard deviation.

Figure 3 Change from baseline in glycemic parameters after supplementation with placebo or Diabetinol^®.

Notes: The mean (± SD) change from baseline in fasting serum (A) blood glucose, (B) fasting insulin, (C) HbA_1c levels, and (D) blood glucose levels 2 hours PP after 12 and 24 weeks of supplementation with placebo (N=19, white) or Diabetinol^® (N=15, gray). *P=0.08; **P=0.05; ^#P=0.07 as compared to baseline. Results are presented only for the participants that completed the entire study.
Abbreviations: FBG, fasting blood glucose; HbA_1c, hemoglobin A_1c; PP, postprandial; SD, standard deviation.

Figure 4 Four-hour postprandial serum glucose levels after supplementation with placebo or Diabetinol^®.

Notes: The mean (± SD) 4-hour postprandial serum glucose levels in participants aged 40–60 years at baseline (diamonds, straight line) and after 12 (squares, hatched line) and 24 weeks (triangles, dotted line) of supplementation with (A) placebo or (B) Diabetinol^®.
Abbreviations: min. minutes, SD, standard deviation.

Figure 5 Change from baseline in blood lipid parameters after supplementation with placebo or Diabetinol^®.

Notes: The mean (± SD) change from baseline in (A) triglyceride, (B) total cholesterol, (C) HDL-C, and (D) LDL-C concentrations after 12 and 24 weeks of supplementation with placebo (white) or Diabetinol^® (gray).
Abbreviations: HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; SD, standard deviation.