HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes

Résumé

Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose which is absorbed from the intestine into the blood leading to a rise in glucose (blood sugar) which triggers the secretion of insulin. Insulin binds to cells in several tissues including liver, muscle, and fat, triggering cells 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. High insulin levels also increase the incidence of cancers, stroke, and dementia. 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 insulin resistance may prevent the onset of diabetes or even reverse diabetes if diagnosed in its early stages before substantial damage to the pancreas has occurred. HP-211 is a botanical extract whose active ingredients are derived from herbs and vegetables present in normal diets. HP-211 has been shown in laboratory studies in cell culture, in animal studies, and in a previous Phase 1 study to enhance the ability of insulin to stimulate glucose uptake into cells. Thus, HP-211 may reduce the blood glucose and circulating insulin levels of subjects with type 2 diabetes after a meal. HP-211 may also reduce glucose and insulin responses to a greater extent in insulin-resistant as compared to insulin-sensitive subjects. Subjects will take 0, 1, 2 or 3 tablets of HP-211 in the morning and evening for 90 days. Hemoglobin A1c (HbA1c, or "A1c"), a measure of the average amount of glucose present in the blood, will be measured during the trial period.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Change from Baseline in Hemoglobin A1c (HbA1c)

   Least squares mean change from baseline in HbA1c at Week 12, analyzed using a mixed model for repeated measures (MMRM).

   Délai After 12 weeks of treatment.

2. Critère de jugement secondaire

   Change from Baseline in Fasting Blood Glucose

   Change from baseline in fasting blood glucose levels.

   Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

3. Critère de jugement secondaire

   Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Profile

   Mean change from baseline in 7-point SMBG profile, including pre-meal and 2-hour postprandial glucose measurements.

   Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

4. Critère de jugement secondaire

   Proportion of Participants Achieving HbA1c <7.0%

   Percentage of participants achieving HbA1c less than 7.0%.

   Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

5. Critère de jugement secondaire

   Proportion of Participants Achieving HbA1c <6.5%

   Percentage of participants achieving HbA1c less than 6.5%.

   Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

6. Critère de jugement secondaire

   Incidence of Hypoglycemia Events (Levels 1-3) -Treatment emergent adverse events (TEAEs) -Serious Adverse Events (SAEs)

   Number and percentage of participants experiencing hypoglycemia events classified as Levels 1 through 3.

   Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

7. Critère de jugement secondaire

   Change from Baseline in Body Weight

   Change from baseline in body weight measured in kilograms.

   Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

8. Critère de jugement secondaire

   Incidence of Treatment-Emergent Adverse Events (TEAEs)

   Number and percentage of participants experiencing treatment-emergent adverse events.

   Délai From first dose through Week 16

9. Critère de jugement secondaire

   Incidence of Serious Adverse Events (SAEs)

   Number and percentage of participants experiencing serious adverse events.

   Délai From first dose through Week 16

10. Critère de jugement secondaire

    Change from Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQs/DTSQc) Score

    Change from baseline in patient-reported treatment satisfaction using DTSQs and DTSQc instruments. * The DTSQs score ranges from 0 to 6 per item with totals ranging from 0 to 36, with higher scores indicating greater treatment satisfaction. * The DTSQc measures change in satisfaction, with item scores typically ranging from -3 to +3 and totals ranging from -18 to +18, where positive scores indicate improvement and negative scores indicate worsening of treatment satisfaction.

    Délai Week 12

11. Critère de jugement secondaire

    Change from Baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QOL) Score

    Change from baseline in patient-reported quality of life using the ADD-QOL instrument. * Change from baseline in patient-reported treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and change version (DTSQc). * The DTSQs total score ranges from 0 to 36, with higher scores indicating greater treatment satisfaction. * The DTSQc measures change in satisfaction, with item scores typically ranging from -3 to +3, where positive scores indicate improvement and negative scores indicate worsening of treatment satisfaction.

    Délai Week 12

12. Autre critère de jugement

    Exploratory: Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)

    Change from baseline in hs-CRP levels.

    Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

13. Autre critère de jugement

    Exploratory: Change from Baseline in Lipid Profile Parameters

    Change from baseline in lipid parameters including total cholesterol, LDL, HDL, and triglycerides.

    Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

14. Autre critère de jugement

    Exploratory: Exploratory: Change from Baseline in Mean Glucose (CGM)

    Change from baseline in mean glucose measured by continuous glucose monitoring (CGM), reported in mg/dL.

    Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

15. Autre critère de jugement

    Exploratory: Change from Baseline in Time in Range (CGM)

    Change from baseline in time in target glucose range (70-180 mg/dL) measured by continuous glucose monitoring (CGM), reported as percentage of time within range.

    Délai After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.

16. Autre critère de jugement

    Exploratory: Change from Baseline in Glucose Excursion During 75 g Oral Glucose Tolerance Test (OGTT)

    Change from baseline in glucose excursion during OGTT, assessed using serial glucose measurements over 0-120 minutes.

    Délai Week 12

17. Autre critère de jugement

    Exploratory: Change from Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Change from baseline in insulin resistance as measured by HOMA-IR.

    Délai Week 12

18. Autre critère de jugement

    Exploratory: Change from Baseline in Matsuda Index

    Change from baseline in insulin sensitivity as measured by the Matsuda Index.

    Délai Week 12

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