Brief Summary

Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose (blood sugar) which is absorbed from the intestine into the blood leading to a rise in glucose which triggers the secretion of insulin. Insulin binds to cells in the liver, muscle and fat, triggering them to take up glucose and bring the blood glucose level back to normal. A high blood sugar level is known as diabetes. The most common form of diabetes, type 2 diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate glucose uptake into cells. The body compensates for insulin resistance by making more insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to control blood glucose. The high blood glucose and insulin levels lead to long-term complications such as heart attacks, kidney failure, reduced sensation and poor circulation in the feet and legs. Reducing blood glucose levels with oral medications and insulin reduces risk of diabetic complications. There are several types of oral medications available for treating diabetes; however, they do not always control blood glucose adequately. In addition, these drugs have complications and are not used to treat insulin resistance and prediabetes - a condition when blood glucose is higher than normal but not high enough to be classified as diabetes. Prediabetes often progresses to diabetes over a period of months or years. Effective and safe treatments for prediabetes could prevent or delay the onset of diabetes. Axulin is a natural health product consisting of a mixture of extracts - derived from herbs and vegetables present in normal diets - which has been shown in cell culture and in animal studies to increase the ability of insulin to stimulate glucose uptake into cells. The active ingredient in Axulin is a botanical extract designated HP-211. Thus, HP-211 may reduce the blood glucose and insulin levels of subjects without diabetes after eating. HP-211 may also reduce glucose and insulin responses to a larger extent in insulin-resistant as compared to insulin-sensitive subjects. Subjects will take 0g, 2g, or 4g of capsules or tablets in the morning after an overnight fast; 40 minutes later they will consume 75g glucose dissolved in 300ml water. Blood glucose, insulin and fats will be measured before and for 2 hours after the glucose drink.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Apr 2017

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

April 26, 2017

Completed

Same day until next milestone

Study Start

First participant enrolled

April 26, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

April 20, 2020

Completed

Last Updated

April 20, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

April 26, 2017

Results QC Date

October 11, 2019

Last Update Submit

April 17, 2020

Conditions

Insulin Resistance, Diabetes

Outcome Measures

Primary Outcomes (1)

Percentage Change in Area Under The Curve (AUC) for Blood Glucose 0-2 Hours
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.
0, 15, 30, 45, 60, 90, and 120 minutes post-dose

Secondary Outcomes (6)

Blood Glucose Area Under The Curve (AUC) 0-2 Hours
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Serum Insulin Area Under The Curve (AUC) 0-2 Hours
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Percentage Change in Area Under The Curve (AUC) for Serum Insulin 0-2 Hours
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Insulinogenic Index
Baseline and 30 minutes
Matsuda Insulin Sensitivity Index
0, 30, 60, 90, and 120 minutes post-dose
+1 more secondary outcomes

Other Outcomes (2)

Effect of Axulin in Lean vs. Overweight Participants
0, 15, 30, 45, 60, 90, and 120 minutes post-dose
Effect of Capsules vs. Tablets
0, 15, 30, 45, 60, 90, and 120 minutes post-dose

Study Arms (2)

Lean Participants

OTHER

Participants with BMI \>18.5 and \<25.0kg/m²

Other: Placebo capsulesOther: 2g capsulesOther: 4g capsulesOther: Water ControlOther: 2g tabletsOther: 4g tablets

Overweight/Obese Participants

OTHER

Participants with BMI ≥25.0 and \<35.0kg/m²

Other: Placebo capsulesOther: 2g capsulesOther: 4g capsulesOther: Water ControlOther: 2g tabletsOther: 4g tablets