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New treatment option for Type 2 Diabetes
Official title Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
ClinicalTrials.gov ID: NCT07296484
What this study is testing
What is clofutriben?
clofutriben is an investigational medicine, being studied as a potential treatment for type 2 diabetes.
Also referred to as SPI-62, ASP3662.
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
- CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- 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 18 and older
You may be able to join if
- From Screening 1
- Age at least 18 years.
- HbA1c ≥7.5% documented within 3 months prior to Screening 1. (The historical HbA1c value must have been obtained after at least 2 months on the...
- Treatment with stable and adequate doses of ≥2 injectable or oral ADMs. (An ADM will be deemed stable if the dose has been the same for at least 3...
- Adequate total daily insulin is defined as at least 0.3 units/kg/day. Insulin dose will be deemed stable with adjustments of up to 20% total daily...
You likely can't join if
- New-onset diabetes (onset \<1 year in the past).
- Unwillingness to maintain with current glucose-lowering regimen during the trial.
- Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.
- Unwillingness to comply with CGM or other trial procedures.
- Investigator considers the patient will otherwise be unwilling or unable to complete the trial.
- Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.
See the full eligibility criteria
Who can join
- From Screening 1
- Age at least 18 years.
- HbA1c ≥7.5% documented within 3 months prior to Screening 1. (The historical HbA1c value must have been obtained after at least 2 months on the current [as of Screening 1] regimen).
- Treatment with stable and adequate doses of ≥2 injectable or oral ADMs. (An ADM will be deemed stable if the dose has been the same for at least 3 months prior to Screening 1 and without change between Screening 1 and...
- Adequate total daily insulin is defined as at least 0.3 units/kg/day. Insulin dose will be deemed stable with adjustments of up to 20% total daily dose during the 3 months prior to Screening 1 or between Screening 1 and...
- Use of insulin pumps or insulin brand changes (e.g., due to insurance change or shortage) are to be discussed with the MM.
- At least one of the following
- ≥3 stable and adequate ADMs;
- diabetes complication (retinopathy, nephropathy, neuropathy, atherosclerotic heart disease);
- hypertension requiring ≥2 adequately dosed AHMs;
- adequately dosed basal or basal plus prandial insulin in addition to at least 1 other ADM; and
- adequately dosed incretin agonist (a single or combination agent counts as one ADM) in addition to at least 1 other ADM;
- evidence or history of osteoporosis or non-traumatic fracture (e.g., vertebral body compression);
- or established diagnosis of a neoplastic (non-malignant) source of hypercortisolism and have failed, are ineligible for, or declined surgery. At DST Post-DST cortisol level \>1.8 µg/dL and serum dexamethasone ≥140...
- HbA1c ≥7.5% at Screening 2. At Day 1
- No change in, or initiation of, medications for hypertension within 1 month prior to Day 1.
What rules you out
- New-onset diabetes (onset \<1 year in the past).
- Unwillingness to maintain with current glucose-lowering regimen during the trial.
- Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.
- Unwillingness to comply with CGM or other trial procedures.
- Investigator considers the patient will otherwise be unwilling or unable to complete the trial.
- Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.
- Evidence for significant hypoglycemia while on their current diabetic treatment regimen(This includes episodes of symptomatic Level 3 hypoglycemia requiring external assistance for recovery, or CGM-documented prolonged...
- Any of the following in medical history:
- Type 1 diabetes mellitus (T1D), latent autoimmune diabetes in adults (LADA), or familial forms of maturity-onset diabetes of the young (MODY);
- A hemoglobinopathy or other condition which may interfere with measurement of HbA1c (e.g., sickle cell disease HbSS or other variants HbEE thalassemia, hemolytic anemia, recent blood transfusion);
- Hypersensitivity or severe reaction to dexamethasone;
- Pheochromocytoma, or suspicion thereof;
- Anorexia, or other eating disorder;
- Glucocorticoid resistance;
- Multiple sclerosis;
- Significant hepatic impairment (e.g., Child-Pugh Class B or C);
- Idiopathic thrombocytopenic purpura;
- Untreated or inadequately controlled moderate-to-severe sleep apnea (apnea-hypopnea index ≥15). (Patients whose condition has been well controlled with Continuous Positive Airway Pressure (CPAP) use for at least 3...
- Current alcohol consumption \>14 units/week or \>4 units in a single day for males, or \>7 units/week or \>3 units in a single day for females. (Patients with a CAGE score 2-4 should be evaluated further outside the...
- Untreated or inadequately controlled major depressive disorder, generalized anxiety disorder, bipolar disorder, post-traumatic stress disorder, or schizophrenia.(Patients whose condition has been well controlled with...
- Any other medical condition (including malignancy) that is likely to interfere with trial assessments or the patient's ability to complete the trial.
- Any of the following in medication history:
- Any of the excluded medications listed in Section 6.9;
- Any investigational drug within 4 weeks or within less than five times the drug's half-life, whichever is longer, prior to Screening 1 or between Screening 1 and Day 1;
- Woman of childbearing potential (WOCBP) not willing to adhere to highly effective contraception or strict abstinence for the duration of the trial and for 90 days post completion/discontinuation; and
- Pregnancy (including a positive urine test) or current breast feeding. From Screening 2
- Prior probability of undiagnosed endogenous Cushing syndrome based on either of:
- wo morning serum cortisol values after dexamethasone suppression \>5.0 mcg/dL together with plasma dexamethasone \>140 ng/mL; or
- a morning serum cortisol value after dexamethasone suppression \>1.8 mcg/dL, together with plasma dexamethasone \>140 ng/mL and any one of the following that is not attributable to an etiology other than endogenous...
- supraclavicular/dorsocervical fat accumulation;
- irounding of the face (especially compared with prior photos);
- skin changes (violaceous striae, skin thinning, or excessive bruising);
- proximal muscle weakness on exam; or
- history of deep vein thrombosis/pulmonary embolism.
- Plans for, or medically unable to forego, treatment for endogenous Cushing syndrome or ACS within the next 8 months. (For clarity, patients with EnCS or ACS, not having such treatment plans, and medically able to forego...
- Severe, poorly controlled hypertension (mean systolic BP \>160 mmHg or mean diastolic BP \>100 mmHg) at Screening 2 or between Screening 2 and Day 1, including by at-home monitoring. (Such patients will be eligible to...
- Positive urine screen for recreational drugs (except tetrahydrocannabinol (THC)).
- Glomerular filtration rate (GFR) (determined using Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) \<45 mL/min/1.73 m².
- Poorly controlled hyperthyroidism/hypothyroidism (confirmed by TSH or Free thyroxine [fT4]).
- Liver enzymes \>3 × upper limit of normal (ULN) (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or bilirubin \>1.5 × ULN.(excepting benign conditions such as Gilbert's)
- Known hypersensitivity to clofutriben or to any of the product
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Tucson, Arizona, United States
- Fountain Valley, California, United States
- Huntington Park, California, United States
- La Mesa, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- San Diego, California, United States
- Edgewater, Florida, United States
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Port Charlotte, Florida, United States
- Port Orange, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Sioux City, Iowa, United States
+ 35 more site(s).
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 study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Tucson, Arizona, United States; Fountain Valley, California, United States; Huntington Park, California, United States; La Mesa, California, United States; Long Beach, California, United States and 49 more location(s). 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.