What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as pioglitazone and gliclazide, have known side effects. Pioglitazone can cause weight gain, edema, and an increased risk of heart failure. Gliclazide, a sulfonylurea, may lead to hypoglycemia and weight gain. Diazoxide, which activates CNS control centers to regulate glucose production, can cause fluid retention, hyperglycemia, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes, focusing on various mechanisms to control blood glucose levels. While Diazoxide specifically targets CNS control centers to regulate endogenous glucose production, other approved treatments include GLP-1 receptor agonists like exenatide and liraglutide, which enhance insulin secretion and inhibit glucagon release. Additionally, SGLT2 inhibitors such as dapagliflozin reduce glucose reabsorption in the kidneys, and DPP-4 inhibitors like alogliptin prolong the action of incretin hormones. These diverse approaches aim to improve glycemic control through different physiological pathways.

What other types of research exist?

Promising novel alternatives to Diazoxide for Type 2 Diabetes patients include LN 5330 and Go.8288. Both have shown potential in regulating glucose levels and pancreatic hormone secretion. Discuss these options with your healthcare provider to determine the best treatment plan.

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Potassium Channel Opener

Diazoxide for Type 2 Diabetes

Phase 2

Recruiting

Led By Meredith Hawkins, M.D., M.S.

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No family history of diabetes among first degree relatives (eg. mother, father)

Not suffering from a previously diagnosed proliferative retinopathy, significant diabetic renal disease or severe neuropathy (including cardiovascular and gastrointestinal autonomic dysfunction).

Must not have

Coagulopathy

History of chronic liver disease, active hepatitis infection, HIV/AIDS, chronic kidney disease (stage 3 or greater), active cancer, cardiovascular disease or other heart disease, systemic rheumatologic conditions, seizures, bleeding disorders, muscle disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration

Summary

This trial is testing diazoxide, a drug that activates parts of the brain, on people with type 2 diabetes. The goal is to see if it can help reduce the amount of glucose produced by the liver. By doing so, it may help manage high blood sugar levels in these patients. Diazoxide has been shown to improve blood sugar levels, help with weight loss, and affect certain genes in animal studies.

Who is the study for?

This trial is for adults aged 21-70 with type 2 diabetes, having an A1c level between 8.0-12.0%, and a BMI under 35 without severe diabetic complications or family history of diabetes. Healthy participants with no diabetes can also join if they meet the age, BMI, and blood sugar criteria.

What is being tested?

The study tests how diazoxide affects liver glucose production in people with type 2 diabetes compared to a placebo and nicotinic acid. It aims to understand the brain's role in regulating blood sugar levels by potentially activating certain control centers.

What are the potential side effects?

Possible side effects include low blood sugar (hypoglycemia), digestive issues, potential allergic reactions to medications used during the study, and changes in heart rate or blood pressure due to nicotinic acid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My immediate family does not have a history of diabetes.

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I do not have severe eye, kidney, or nerve problems related to diabetes.

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I am between 21 and 70 years old.

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I have passed a drug test recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder.

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I do not have chronic liver, kidney diseases, HIV/AIDS, active cancer, heart disease, rheumatic conditions, seizures, bleeding or muscle disorders.

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I have had surgery to remove an endocrine gland, but not my thyroid.

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A family member had a heart-related death at a young age.

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I am experiencing extreme thirst and urination.

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I have serious liver problems.

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I have been diagnosed with severe anemia.

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I have serious kidney problems.

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I drink less than the maximum daily and weekly alcohol limits.

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I am either younger than 21 or older than 70.

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My cholesterol levels are very high and not under control.

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My BMI is over 35.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Endogenous glucose production (EGP) rate

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: T2D (Nicotinic Acid + placebo for diazoxide)Experimental Treatment2 Interventions

Pancreatic clamp study will be done after lowering free fatty acids with a nicotinic acid (Niacin) infusion in type 2 diabetic participants, and after giving a taste-matched placebo for Diazoxide (Proglycem) to type 2 diabetic participants.

Group II: T2D (Diazoxide)Experimental Treatment1 Intervention

Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to type 2 diabetic participants.

Group III: T2D (Diazoxide + Nicotinic Acid)Experimental Treatment2 Interventions

Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to type 2 diabetic participants after lowering free fatty acids with a nicotinic acid (Niacin) infusion.

Group IV: Non-diabetic (Diazoxide)Experimental Treatment1 Intervention

Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to non-diabetic participants.

Group V: Non-diabetic (Diazoxide + Nicotinic Acid)Experimental Treatment2 Interventions

Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to non-diabetic participants after lowering free fatty acids with a nicotinic acid (Niacin) infusion

Group VI: Experimental: Non-diabetic (Nicotinic Acid + placebo for diazoxide)Experimental Treatment2 Interventions

Pancreatic clamp study will be done after lowering free fatty acids with a nicotinic acid (Niacin) infusion in non-diabetic participants, and after giving a taste-matched placebo for Diazoxide (Proglycem) toon-diabetic participants.

Group VII: Non-diabetic (Placebo)Placebo Group1 Intervention

Pancreatic clamp study will be done after giving a taste-matched placebo for Diazoxide (Proglycem) to non-diabetic participants.

Group VIII: T2D (Placebo)Placebo Group1 Intervention

Pancreatic clamp study will be done after giving a taste-matched placebo for Diazoxide (Proglycem) to type 2 diabetic participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Nicotinic acid

2018

Completed Phase 4

~720

Diazoxide

2006

Completed Phase 4

~80

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include medications like Diazoxide, which activates central nervous system (CNS) control centers to regulate endogenous glucose production, potentially reducing excessive glucose levels produced by the liver. This is particularly important for Type 2 Diabetes patients as it addresses one of the core issues of the disease: impaired glucose regulation. Other treatments include insulin therapy, which directly supplements insulin levels to help cells absorb glucose; metformin, which reduces hepatic glucose production and improves insulin sensitivity; and sulfonylureas, which stimulate pancreatic beta-cells to release more insulin. These treatments are crucial for managing blood glucose levels, preventing complications, and improving overall metabolic control in patients with Type 2 Diabetes.

Coupling of beta-cell desensitization by hyperglycemia to excessive stimulation and circulating insulin in glucose-infused rats.Differences in K+ permeability between cultured adult and neonatal rat islets of Langerhans in response to glucose, tolbutamide, diazoxide, and theophylline.Central insulin-mediated regulation of hepatic glucose production [Review].