Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function
It is reported that pancreatic beta cell function is already declined at pre-diabetic stage,
impaired glucose tolerance (IGT). It has not been clarified whether inhibitors of the
dipeptidyl peptidase IV enzyme (DPP-IV inhibitors) improve beta cell function on human
pancreas, however, if efficacy is ensured, they may become the first medicine to be chosen
for treatments of type 2 diabetes and IGT.
In this trial, a DPP-IV inhibitor, Alogliptin, or Metformin are given to diabetic patients
whose HbA1c level is below 7.9%. Oral glucose tolerance test (OGTT) will be conducted
before, a year after, and two years after the beginning of the trial and beta cell function
will be evaluated.
Patients will be randomly allocated to two groups. They will receive either Alogliptin or
Metformin.
Alogliptin: The investigators will start with 25 mg QD and the dose will be maintained.
Metformin: The investigators will start with 250 mg QD and the dose will be slowly increased
to 750 mg TID. The dose increase is possible up to its maximum, 2250 mg, so that HbA1c is
maintained below 6.9%. However, increase in dose with elder patients requires careful
consideration.
Participants taking part in this study will receive dietary and exercise coaching.
Participation in this study is expected to last up to 2 years.
Patients will terminate from the trial when their HbA1c exceeds 8.4% for more than three
months.
The investigators will evaluate beta cell function by conducting 75 g OGTT before, a year
after, and two years after the beginning of the trial. Alogliptin or Metformin will be
stopped three days before the OGTT. The investigators will make sure that urine ketone is
negative before an oral glucose load.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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