Effects of Alogliptin on Pancreatic Beta Cell Function

February 23, 2011 updated by: Aichi Gakuin University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 464-8650
        • Recruiting
        • Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
        • Contact:
        • Principal Investigator:
          • Takahiro Tosaki, MD, PhD
        • Sub-Investigator:
          • Keiko Naruse, MD, PhD
      • Nagoya, Aichi, Japan, 468-0009
        • Not yet recruiting
        • Tosaki Clinic for Diabetes and Endocrinology
        • Principal Investigator:
          • Takahiro Tosaki, MD, PhD
        • Contact:
      • Okazaki, Aichi, Japan, 444-0008
        • Recruiting
        • Diabetes Clinic, Okazaki East Hospital
        • Principal Investigator:
          • Takahiro Tosaki, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Chizuko Suzuki, MD, PhD
        • Sub-Investigator:
          • Maiko Mizutani, MD, PhD
    • Mie
      • Yokkaichi, Mie, Japan, 510-0016
        • Recruiting
        • Diabetes Center, Yokkaichi Social Insurance Hospital
        • Principal Investigator:
          • Takahiro Tosaki, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Miho Miyoshi, MD
        • Sub-Investigator:
          • Tomoki Majima, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alogliptin
Alogliptin 25 mg
Drug: Alogliptin
Alogliptin 25 mg, tablets, orally, once daily : two years
Other Names:
  • Nothing
Active Comparator: Metformin
Metformin 750 mg
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 %.

Other Names:
  • Nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
beta cell function evaluated from 75 g OGTT
Time Frame: 2 years

75 g OGTT: glucose level, blood insulin level, c-peptide immunoreactivity (pre-test, 30 mins, 60 mins, 120 mins), fasting blood proinsulin

Oral glucose tolerance test ( OGTT ) will be conducted before, a year after, and two years after the beginning of the trial.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1,5-AG level
Time Frame: 2 years
Secondary end points include HbA1c level.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aichi Gakuin University

Investigators

  • Study Chair: Takahiro Tosaki, MD, PhD, Aichi Gakuin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

February 23, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

February 24, 2011

Last Update Submitted That Met QC Criteria

February 23, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGU-248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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