CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Placebo capsules +5 moreother
Likely dose
2g capsulesfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03135015
NCT03135015Phase 1Completed

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

Housey Healthcare ULC·interventional·Posted May 1, 2017·Updated Apr 20, 2020

In Brief

A Phase 1 clinical trial evaluating Placebo capsules, 2g capsules, and 4 other interventions for Insulin Resistance, Diabetes. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 1, 2017
Enrollment StartApr 26, 2017
Primary CompletionJun 21, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.2 years ago

Interventions

Placebo capsulesother

250ml water with 16 x 250mg placebo capsules

2g capsulesother

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

4g capsulesother

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

Water Controlother

250ml water

2g tabletsother

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

4g tabletsother

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