100 Participants Needed

Diazoxide for Type 2 Diabetes

MH
Overseen ByMeredith Hawkins, M.D., M.S.
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, a negative drug screen is required, which means you cannot have certain drugs in your system. It's best to discuss your specific medications with the trial coordinators.

Is diazoxide safe for humans?

Diazoxide has been associated with several adverse effects, including hyperglycemia (high blood sugar), hyperosmolar hyperglycemic syndrome (a serious condition related to high blood sugar), pulmonary hypertension (high blood pressure in the lungs), and neutropenia (low white blood cell count). In a study, 30.5% of patients experienced at least one adverse reaction, with common issues being excessive hair growth and water retention.12345

How is the drug diazoxide different from other treatments for type 2 diabetes?

Diazoxide is unique because it is primarily used to treat conditions with excessive insulin, like hyperinsulinism, by reducing insulin release, which is different from most type 2 diabetes treatments that focus on increasing insulin sensitivity or production. It can cause hyperglycemia (high blood sugar) as a side effect, which is why it is being explored for type 2 diabetes.23678

Who Is on the Research Team?

MH

Meredith Hawkins, M.D., M.S.

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your blood sugar levels are normal when fasting and over time.
I am 21-70 years old, have a BMI under 35, no drug use, normal blood sugar levels, and no close family with diabetes.
My immediate family does not have a history of diabetes.
See 6 more

Exclusion Criteria

You smoke more than 10 cigarettes a day.
You have a significant change in your white blood cell count.
I have a blood clotting disorder.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pancreatic clamp studies with administration of diazoxide or placebo, with or without nicotinic acid, to assess endogenous glucose production

7 hour infusions, 4 days in total, separated at least 1 month apart

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Diazoxide
Trial Overview 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.
How Is the Trial Designed?
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.

Diazoxide is already approved in United States for the following indications:

🇺🇸
Approved in United States as Proglycem for:
  • Hypoglycemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Meredith Hawkins

Lead Sponsor

Trials
2
Recruited
110+

Albert Einstein College of Medicine

Lead Sponsor

Trials
302
Recruited
11,690,000+

American Diabetes Association

Collaborator

Trials
148
Recruited
102,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

In a study of 295 infants and children treated with diazoxide for hyperinsulinism, 2.4% developed pulmonary hypertension, particularly in those with underlying risk factors like respiratory failure and structural heart disease.
The study also found a notable prevalence of other adverse events, including neutropenia (15.6%), thrombocytopenia (4.7%), and hyperuricemia (5.0%), highlighting the importance of proactive screening for these side effects in patients receiving diazoxide.
Prevalence of Adverse Events in Children With Congenital Hyperinsulinism Treated With Diazoxide.Herrera, A., Vajravelu, ME., Givler, S., et al.[2019]
Diazoxide, a benzothiadiazine, has been shown to effectively manage hypoglycemia in frail patients, particularly those at surgical risk.
This case report highlights the successful treatment of insulinoma with diazoxide, suggesting its potential utility in similar clinical scenarios.
A case of insulinoma effectively treated with low-dose diazoxide.Yasuda, A., Seki, T., Kitajima, N., et al.[2020]
A 5-year-old girl developed hyperosmolar hyperglycemic syndrome (HHS) with a serum glucose level of 529 mg/dL while being treated with diazoxide and diuretics, highlighting the potential risk of hyperglycemia associated with diazoxide use.
Even at low blood levels of diazoxide (25 µg/dL), it can still lead to hyperglycemia, indicating that patients on diazoxide and diuretics require careful monitoring to prevent complications like HHS.
Hyperosmolar hyperglycemic syndrome induced by diazoxide and furosemide in a 5-year-old girl.Nakazawa, H., Naruse, Y., Mori, M., et al.[2021]

Citations

Prevalence of Adverse Events in Children With Congenital Hyperinsulinism Treated With Diazoxide. [2019]
A case of insulinoma effectively treated with low-dose diazoxide. [2020]
Hyperosmolar hyperglycemic syndrome induced by diazoxide and furosemide in a 5-year-old girl. [2021]
Safety and effectiveness, including intelligence prognosis, of diazoxide in pediatric patients with hyperinsulinemic hypoglycemia: special survey in Japan (long-term, all-case survey). [2020]
Management and Appropriate Use of Diazoxide in Infants and Children with Hyperinsulinism. [2021]
Safety and efficacy of low-dose diazoxide in small-for-gestational-age infants with hyperinsulinaemic hypoglycaemia. [2022]
Rate of Serious Adverse Events Associated with Diazoxide Treatment of Patients with Hyperinsulinism. [2019]
Use of euglycaemic clamping in evaluation of diazoxide treatment of insulinoma. [2019]
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