Effects of Alogliptin on Pancreatic Beta Cell Function

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aichi Gakuin University
• Treatments: Alogliptin; Metformin

Criteria

Inclusion Criteria:

• Patients who are diagnosed as type 2 diabetes with HbA1c level below 7.9% and haven't received oral hypoglycemic agents or insulin treatments for the past three months.

Exclusion Criteria:

• Patients whose 75 g OGTT 30-minutes insulin secretion exceeds 100 μU/ml

• Patients with renal failure with serum creatinine level ≧ 1.2

• Patients with hepatocirrhosis

• Patients with proliferative diabetic retinopathy or worse

• Patients with acute infectious disease

• Patients who are treated with steroids

• Patients with cancer

• Pregnant patients

• Patients with malfunction of the heart (NYHA classification III-IV)

• Patients who are decided to be inappropriate subjects by study physicians