Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSparrow Pharmaceuticals
About this trial
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. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 Day 1) (An ADM dose will be deemed adequate if it is at or above the maximal labelled dose, or a sub-maximal, but not starting, dose if limited by tolerability (confer with MM if less than half-maximal dose).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
clofutriben
DrugHSD-1 inhibitor
Placebo
DrugPlacebo
Treatment groups
1,500 Participants
are divided into 5 treatment groupsGroup A: Dose 1Experimental treatment 1 intervention
Group B: Dose 2Experimental treatment 1 intervention
Group C: Dose 3Experimental treatment 1 intervention
Group D: Dose 4Experimental treatment 1 intervention
Group E: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with both morning serum cortisol >1.8 mg/dL and morning plasma dexamethasone >=140 ng/dL (single composite endpoint) after a single dexamethasone 1 mg dose taken the prior night.
To assess prevalence in the trial population of morning cortisol non-suppression by a single dexamethasone 1 mg dose.
Time frame
8-10 hours after the dexamethasone 1 mg dose.2
Glycated hemoglobin A1c (%) change from baseline to Week 24 by treatment.
To assess glycated hemoglobin A1c (%) changes, compared to placebo, in patients who receive each of 4 daily clofutriben doses for 24 weeks.
Time frame
24 weeks.Secondary outcomes
1
Fasting plasma glucose (mmol/L) change from baseline to Week 24 by treatment.
To assess glucose (mmol/L) changes, compared to placebo, in patients who receive each of 4 daily clofutriben doses for 24 weeks.
Time frame
24 weeksOther outcomes
1
To evaluate the safety of clofutriben in participants with T2D and EC.
Frequency of TEAEs (treatment-emergent adverse even) by clofutriben dose
Time frame
From enrollment until end of trial 9 monthSponsors and contacts
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Source ClinicalTrials.gov