Participants with BMI >18.5 and <25.0kg/m²

Participants with BMI ≥25.0 and <35.0kg/m²

Participants with BMI >18.5 and <25.0kg/m². All participants received each of the 6 interventions in a randomized manner.

Lean Participants

Participants with BMI ≥25.0 and <35.0kg/m². All participants received each of the 6 interventions in a randomized manner.

Overweight/Obese Participants

Total

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

Body Mass Index (BMI)

Percentage change in the incremental area under the glucose response curve (AUC) after 75g glucose for capsules and tablets containing Axulin powder relative to the water control. Incremental AUC is the AUC below the curve above the fasting level; area below fasting is ignored. Percentage change will be calculated as 100 x (A-P)/P where A and P are the mean AUC's after Axulin and water control treatments, respectively. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done. The percentage changes will be considered to be significant if the difference in mean AUC is significant.

All Participants randomized to receive 250ml water.

Water Control

All Participants randomized to receive 250ml water with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.

2g Capsules

All Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.

4g Capsules

All Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.

Placebo Capsules

All Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.

2g Tablets

All Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.

4g Tablets

Percentage Change in Area Under The Curve (AUC) for Blood Glucose 0-2 Hours

Incremental area under the blood glucose response curve (AUC) is the AUC below the glucose response curve above the fasting level; area below fasting is ignored. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done.

All Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.

Blood Glucose Area Under The Curve (AUC) 0-2 Hours

Incremental area under the serum insulin response curve (AUC) is the AUC below the insulin response curve above the fasting level; area below fasting is ignored. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done.

Serum Insulin Area Under The Curve (AUC) 0-2 Hours

Percentage change in the incremental area under the insulin response curve (AUC) after 75g glucose for the capsules containing Axulin powder relative to the water control. Incremental AUC is the AUC below the curve above the fasting level; area below fasting is ignored. Percentage change will be calculated as 100 x (A-P)/P where A and P are the mean AUC's after Axulin and water control treatments, respectively. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done. The percentage changes will be considered to be significant if the difference in mean AUC is significant.

Percentage Change in Area Under The Curve (AUC) for Serum Insulin 0-2 Hours

Insulinogenic Index is an index of the ability of a change in blood glucose to stimulate an increase in serum insulin. It is a unitless measure with higher numbers indicating improved beta cell function. It is calculated by dividing the change in serum insulin between 0 and 30 minutes by the change in blood glucose between 0 and 30 minutes.

Insulinogenic Index

Matsuda Insulin Sensitivity Index is an index of whole body insulin sensitivity derived from glucose and insulin responses after a 75g Oral Glucose Tolerance Test (OGTT). It is calculated by 10000 divided by the square root of (FG*FI*MG*MI) where FG is fasting glucose, FI is fasting insulin, MG is the mean AUC for blood glucose at 0, 30, 60, 90 and 120 minutes and MI is the mean AUC for serum insulin at 0, 30, 60, 90 and 120 minutes.

Matsuda Insulin Sensitivity Index

Insulin Secretion-Sensitivity Index-2 (ISSI-2) is an index of β-cell function with insulin secretion adjusted for whole body insulin sensitivity. It is calculated by the total area under the curve for serum insulin divided by the area under the curve for blood glucose, and that result times the Matsuda insulin sensitivity index (defined above).

ISSI-2 Index of Beta-cell Function

Percentage change in blood glucose area under the curve (AUC) in lean participants compared to overweight participants.

Lean Participants randomized to receive 250ml water.

Water Control, Lean Participants

Overweight Participants randomized to receive 250ml water.

Water Control, Overweight Participants

Lean Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.

2g Capsules, Lean Participants

Overweight Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.

2g Capsules, Overweight Participants

Lean Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.

4g Capsules, Lean Participants

Overweight Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.

4g Capsules, Overweight Participants

Lean Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.

2g Tablets, Lean Participants

Overweight Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.

2g Tablets, Overweight Participants

Lean Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.

4g Tablets, Lean Participants

Overweight Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.

4g Tablets, Overweight Participants

Lean Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.

Placebo Capsules, Lean Participants

Overweight Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.

Placebo Capsules, Overweight Participants

Effect of Axulin in Lean vs. Overweight Participants

Percentage change in blood glucose area under the curve (AUC) elicited by capsules compared to the same dose of tablets.

Effect of Capsules vs. Tablets

Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the water control and the placebo capsule treatments will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.

Blood Glucose Change From Baseline in the Water Control Compared to the Placebo Capsules at 90 Minutes for All Participants

Incremental area under the blood glucose response curve (AUC) will be computed using the values recorded at 60 minutes and beyond. The blinded AUC results for the Axulin capsule treatments and the water control will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 3 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.

60-Minute Blood Glucose Area Under the Curve (AUC)

Change from baseline (CFB) in blood glucose will be computed at 90 and 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.

Blood Glucose Change From Baseline at 90 and 120 Minutes in All Participants

Change from baseline (CFB) in blood glucose will be computed at 90 and 120 minutes for the Lean Participants. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.

Blood Glucose Change From Baseline at 90 and 120 Minutes in Lean Participants

Change from baseline (CFB) in blood glucose will be computed at 90 and 120 minutes for the Obese/Overweight Participants. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.

Blood Glucose Change From Baseline at 90 and 120 Minutes in Overweight Participants

Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.

Insulin Change From Baseline at 90 Minutes in All Participants

Overall Study

Project Manager

Participants randomized to receive 250ml water.

Water Control, Overweight/Obese Participants

Participants randomized to receive 250ml water.with 16 x 250mg placebo capsules.

Placebo Capsules, Overweight/Obese Participants

Participants randomized to receive 250ml water.with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules.

2g Capsules, Overweight/Obese Participants

Participants randomized to receive 250ml water with 16 x 250mg capsules containing Axulin powder.

4g Capsules, Overweight/Obese Participants

Participants randomized to receive 250ml water with 2 x 1g tablets containing Axulin powder.

2g Tablets, Overweight/Obese Participants

Participants randomized to receive 250ml water with 4 x 1g tablets containing Axulin powder.

4g Tablets, Overweight/Obese Participants

Insulin Resistance, Diabetes

250ml water with 16 x 250mg placebo capsules

Placebo capsules

250ml water with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules

2g capsules

250ml water with 16 x 250mg capsules containing Axulin powder

4g capsules

250ml water with 2 x 1g tablets containing Axulin powder

2g tablets

250ml water with 4 x 1g tablets containing Axulin powder

diabetes complications/tyrosine

Acute Effect of HP-211 (Axulin) on Blood Glucose and Serum Insulin Responses in Healthy Lean and Overweight Humans

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