Phase 2 Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are at least 18 years old.
• People whose blood sugar control measure (HbA1c) was 7.5% or higher within the 3 months before the first screening visit, measured after at least 2 months on their current diabetes treatment.
• People who have been taking at least 2 diabetes medications (tablets or injections) at stable, adequate doses for at least 3 months.
• People taking insulin who are using a daily dose of at least 0.3 units per kilogram of body weight, with the dose remaining fairly consistent (within 20%) over the past 3 months.
• People who meet at least one of the following additional conditions:
  • Taking 3 or more stable, adequate diabetes medications
  • Having a diabetes-related complication such as eye, kidney, or nerve damage, or heart disease related to hardening of the arteries
  • Having high blood pressure that requires 2 or more adequately dosed blood pressure medications
  • Taking basal insulin (with or without mealtime insulin) plus at least one other diabetes medication at adequate doses
  • Taking an incretin-based medication (such as a GLP-1 or similar agent) plus at least one other diabetes medication at adequate doses
  • Having a history of osteoporosis or a bone fracture that was not caused by injury
  • Having a confirmed diagnosis of a non-cancerous tumour causing excess cortisol (a stress hormone), where surgery has been tried and failed, surgery is not suitable, or the person has chosen not to have surgery
• People whose blood sugar control measure (HbA1c) remains at 7.5% or higher at the second screening visit.
• People who have not started or changed any blood pressure medications within 1 month before the trial start date.
• People who show certain results on a dexamethasone suppression test (a hormone test), unless they already have a confirmed diagnosis of a tumour causing excess cortisol, in which case this test is not required (confirm with trial site).

Who may not be able to join:

• People who were diagnosed with diabetes less than 1 year ago.
• People who are unwilling to stay on their current blood sugar–lowering treatment during the trial.
• People who are unwilling to adjust, add, or stop blood sugar–lowering medications if the trial doctor directs them to.
• People who are unwilling to use a continuous glucose monitor (CGM) or follow other trial procedures.
• People the trial doctor believes will be unable or unwilling to complete the trial.
• People who work night shifts or who are regularly awake between 11pm and 7am.
• People who have had significant low blood sugar episodes on their current diabetes treatment, including episodes requiring help from another person, or frequent or prolonged low blood sugar events recorded by a CGM, within the past 3 months or between screening visits.
• People with a history of Type 1 diabetes, a form of slow-onset autoimmune diabetes (LADA), or certain inherited forms of diabetes (MODY).
• People with a blood condition that may affect the accuracy of the HbA1c test, such as sickle cell disease, thalassaemia, haemolytic anaemia, or a recent blood transfusion.
• People with a known severe reaction or allergy to dexamethasone (a steroid medication used in trial testing).
• People with a known or suspected adrenal gland tumour called a phaeochromocytoma.
• People with anorexia or another eating disorder.
• People with a condition where the body does not respond normally to cortisol (glucocorticoid resistance).
• People with multiple sclerosis.
• People with significant liver disease (such as Child-Pugh Class B or C liver impairment).
• People with a blood platelet disorder called idiopathic thrombocytopenic purpura.
• People with untreated or poorly controlled moderate-to-severe sleep apnoea. People whose sleep apnoea has been well managed with a CPAP machine for at least 3 months before the first screening visit are not automatically excluded.
• People whose alcohol intake exceeds 14 standard drinks per week or 4 in a single day (for males), or 7 per week or 3 in a single day (for females).
• People with untreated or poorly controlled mental health conditions including major depression, generalised anxiety disorder, bipolar disorder, post-traumatic stress disorder, or schizophrenia. People whose condition has been stable and well managed for at least 3 months before the first screening visit are not automatically excluded.
• People with any other medical condition, including cancer, that is likely to interfere with the trial or their ability to complete it.
• People who have taken certain medications listed as excluded by the trial (confirm the specific list with the trial site).
• People who have taken another experimental drug within 4 weeks before the first screening visit, or within a longer period depending on how long that drug stays in the body.
• Women who are able to become pregnant and are not willing to use highly effective contraception or remain strictly abstinent for the full duration of the trial and for 90 days after it ends.
• People who are currently pregnant or breastfeeding.
• People whose hormone test results suggest a higher likelihood of an undiagnosed condition causing the body to produce too much cortisol naturally (endogenous Cushing's syndrome), based on specific blood test results combined with certain physical signs such as fat deposits around the upper back or collar area, a rounder face, skin changes, muscle weakness, or a history of blood clots.
• People who are planning to have treatment for endogenous Cushing's syndrome or a related condition (autonomous cortisol secretion) within the next 8 months, or who are medically unable to delay that treatment.
• People with severely uncontrolled high blood pressure (above 160/100 mmHg) at the second screening visit or before the trial start date.
• People who test positive for recreational drugs (other than cannabis/THC) on a urine screen.
• People whose kidneys are not functioning well enough, based on a specific kidney filtration measurement falling below 45 mL/min/1.73 m².
• People with poorly controlled overactive or underactive thyroid, confirmed by blood tests.
• People with significantly elevated liver enzyme levels or bilirubin on blood tests, unless caused by a known harmless condition such as Gilbert's syndrome.
• People with a known allergy to the trial drug (clofutriben) or any of its ingredients.

Important: Always verify eligibility with the trial site directly before applying.