Type 2 Diabetes Clinical Trial
Official title:
The Effect of Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, on Glycemic Control and Inappropriate Glucagon Secretion in Non-obese Japanese Patients With Type 2 Diabetes.
Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and
insulin resistance. Studies have shown that most of the populations in which insulin
resistance is considered to be the primary pathogenetic cause of diabetes, have a higher
degree of obesity than those of primary insulin defect. Meanwhile, defective early insulin
secretion plays a predominant role in the non-obese subtype of T2DM which includes majority
of Japanese patients.
Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of
T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1)
and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients
with T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial
glucose concentrations through increases in glucose dependent insulin release and
suppression of inappropriate glucagon secretion. Namely, several mechanistic studies using
standardized meal showed that sitagliptin improved glucose control with decreased glucagon
levels and increased insulin concentration in obese or overweight T2DM patients with BMI >
25 kg/m2. However, how sitagliptin affects islet function, including glucagon secretion in
non-obese patients with low insulin secretion are not known. Therefore, the investigators
will examine the effect of sitagliptin on glycemic control and the mechanism involved using
a standardized test meal in non-obese Japanese patients with T2DM whose BMI levels are < 25
kg/m2.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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