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Effects of Alogliptin on Pancreatic Beta Cell Function

NCT01303055 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-02-24

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Alogliptin

Alogliptin 25 mg, tablets, orally, once daily : two years

DRUG

Metformin 750 mg

Metformin 750 mg, tablets, orally, thrice daily: two years The dose increase is possible up to its maximum, 2250 mg, so that HbA1c is maintained below 6.9 %.

Sponsors & Collaborators

  • Aichi Gakuin University

    lead OTHER

Principal Investigators

  • Takahiro Tosaki, MD, PhD · Aichi Gakuin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303055 on ClinicalTrials.gov