Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effects of KDT501 on Metabolic Features in Insulin Resistant Subjects
KDT501 is an orally administered product designed to help control impaired glucose and
insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate
agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein
receptors. Nonclinical studies have also documented the ability of KDT501 to improve insulin
sensitivity and glucose regulation as well as reduce proinflammatory signals. These
properties combined with antihyperglycemic activity and modest, partial agonist effect of
KDT501 at the peroxisome proliferator-activated receptor-gamma (PPARĪ³) receptor suggests an
atypical and pleiotropic mechanism of action for KDT501.
Following providing informed consent, potential subjects will undergo screening procedures to
ensure that they meet all inclusion and exclusion criteria. Following registration on study,
subjects will undergo baseline pretreatment studies, including two abdominal fat biopsies,
one taken after cold challenge, as well as determination of resting metabolic rate, a 4 hour
lipid tolerance test, and a 2 hour euglycemic clamp study. All pretreatment studies in
registered subjects will be performed within 7 days prior to initiating therapy. On the first
day of treatment (Day 0), subjects will take the first 600 mg dose of KDT501 in the clinic,
followed by serum pharmacokinetic (PK) samples being obtained every hour for 6 hours after
dosing. Subjects will then continue dosing as an outpatient, 600 mg po twice daily. All doses
will be taken with meals (breakfast and dinner). On Day 7, subjects will return to the clinic
to undergo safety and laboratory assessments, including PK. On Days 14 and 21, subjects will
again return to the clinic to undergo safety and laboratory assessments. On Day 17 subjects
will return to the clinic for PK studies, as noted below. Treatment in all subjects will end
on Day 28. Rapid PK assessment of drug exposure, defined as AUC0-12h, will be performed
following PK samples drawn at Time 0, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, and 12h on both Days 7
and 17. On Days 11 and 21 (±1day), based on the KDT501 drug exposure level, the subject will
be provided instructions on dose adjustments of KDT501. The maximum allowed KDT501 exposure
ceiling for all subjects enrolled is AUC0-12h = 22,500ng-hr/mL.
n/a
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