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New treatment option for Diabetes Mellitus
Official title Regulation of Endogenous Glucose Production by Central KATP Channels
ClinicalTrials.gov ID: NCT03540758
What this study is testing
What is Diazoxide?
Diazoxide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetes mellitus.
Also referred to as Proglycem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Type 2 diabetes (T2D) affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70. Healthy volunteers may be eligible.
You may be able to join if
- For healthy (non-diabetic) participants:
- Age: 21-70 years old
- Body Mass Index (BMI) under 40 kg/m\^2
- Negative drug screen (see below)
- Normal Hemoglobin A1c (HbA1c) and fasting glucose
You likely can't join if
- Age: Under 21 or over 70 years old
- BMI: \>40 kg/m\^2 for Type 2 Diabetes (T2D) and Non-Diabetic (ND) people
- Blood pressure \>150/90 or \<90/60 on more than one occasion
- Severe polydipsia and polyuria (in people with T2D). Since polydipsia and polyuria are common symptoms of T2D, the distinction "severe" denotes that...
- Urine microalbumin: \>300 mg/g of creatinine (in people with T2D)
- Uncontrolled hyperlipidemia defined as Triglycerides (TG) \> 400 mg/dL and/or Total Cholesterol \>300 mg/dL
See the full eligibility criteria
- For healthy (non-diabetic) participants:
- Age: 21-70 years old
- Body Mass Index (BMI) under 40 kg/m\^2
- Negative drug screen (see below)
- Normal Hemoglobin A1c (HbA1c) and fasting glucose
- In general good health (see below for exclusions)
- Not participating in any other research study besides those done by the study team For T2D participants:
- Age: 21-70 years old
- BMI under 40 kg/m\^2
- Stable and moderate-to-poor glycemic control (HbA1c: 8.0-12.0%)
- Negative drug screen (see below)
- Not suffering from a previously diagnosed proliferative retinopathy, significant diabetic renal disease (urinary microalbumin \<100 μg/dl) or severe peripheral neuropathy (including cardiovascular and gastrointestinal...
- Diabetic people will be otherwise in good health (see below for exclusions), taking no medications that might affect study eligibility based on review by study doctor, and not participating in any other research study...
- Age: Under 21 or over 70 years old
- BMI: \>40 kg/m\^2 for Type 2 Diabetes (T2D) and Non-Diabetic (ND) people
- Blood pressure \>150/90 or \<90/60 on more than one occasion
- Severe polydipsia and polyuria (in people with T2D). Since polydipsia and polyuria are common symptoms of T2D, the distinction "severe" denotes that the subject indicates a worsening in the symptoms and/or an experience...
- Urine microalbumin: \>300 mg/g of creatinine (in people with T2D)
- Uncontrolled hyperlipidemia defined as Triglycerides (TG) \> 400 mg/dL and/or Total Cholesterol \>300 mg/dL
- Clinically significant liver dysfunction including thrombocytopenia (platelets \ 1.5), and/or liver enzymes more than 3 times the upper limit of normal
- Clinically significant kidney dysfunction, Glomerular Filtration Rate (GFR): \<60 mg/dL
- Clinically significant anemia. Prospective people with hemoglobin below the lower limit of 12 g/dl for for men and 11 g/dL for women will be assessed with history and physical exam to rule out clinically significant...
- Clinically significant leukocytosis or leukopenia
- Clinically significant thrombocytopenia or thrombocytosis
- Coagulopathy
- Urine drug screen positive for any of the following: amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone, phencyclidine (PCP). Amphetamines, oxycodone, opiates, methadone, and...
- Urinalysis: Clinically significant abnormalities
- Clinically significant electrolyte abnormalities
- Smoking \>10 cigarettes/day
- Alcohol: Men \>14 drinks/week or \>4 drinks/day, Women \>7 drinks/week or \>3 drinks/day
- 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...
- Surgeries that involve removal of endocrine glands except for thyroidectomy (if euthyroid on thyroid hormone replacement - if such history free thyroxine (fT4) and Thyroid Stimulating Hormone (TSH) will be checked)
- Pregnant women
- Subject enrolled in another study less than one month prior to the anticipated start date of the proposed study, besides those done by our group
- Family history of premature cardiac death
- Allergies to medication administered during study
- Uncontrolled psychiatric disorders
- Any condition which in the opinion of the PI makes the subject ill suited for participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.