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

Conditions

• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HP-211 — DRUG
  HP-211 is an investigational botanical extract derived from Cichorium endivia var. latifolium, Lactuca sativa, and Artemisia dracunculus.
• Placebo — DRUG
  Matching placebo administered orally twice daily (BID).

Study Details

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.

Key Dates

Start date

Feb 3, 2023

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: HP-211 Dose Level 1
  HP-211 0.98grams BID
• Experimental: HP-211 Dose Level 2
  HP-211 1.96grams BID
• Experimental: HP-211 Dose Level 3
  HP-211 2.94grams BID
• Placebo Comparator: HP-211 Dose Level 4
  Placebo BID

Primary Outcome Measure

Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: After 12 weeks of treatment. ]

Central Contacts

• Housey Study Info
  (248) 663-7000
  [email protected]

Locations (25)

Find similar trials in Canoga Park, CA

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