NCT01303055

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

2.8 years

First QC Date

February 23, 2011

Last Update Submit

February 23, 2011

Conditions

Diabetes Mellitus, Type 2

Keywords

Pancreatic beta CellDiabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesMetforminHypoglycemic AgentsPhysiological Effects of DrugsPharmacologic Actionshemoglobin A1c protein, humanOral Glucose Tolerance Test

Outcome Measures

Primary Outcomes (1)

  • beta cell function evaluated from 75 g OGTT

    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 Outcomes (1)

  • 1,5-AG level

    2 years

Study Arms (2)

Alogliptin

EXPERIMENTAL

Alogliptin 25 mg

Drug: Alogliptin

Metformin

ACTIVE COMPARATOR

Metformin 750 mg

Drug: Metformin 750 mg

Interventions

AlogliptinDRUG

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

Also known as: Nothing
Alogliptin
Metformin 750 mgDRUG

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 %.

Also known as: Nothing
Metformin

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University

Nagoya, Aichi-ken, 464-8650, Japan

RECRUITING

Tosaki Clinic for Diabetes and Endocrinology

Nagoya, Aichi-ken, 468-0009, Japan

NOT YET RECRUITING

Diabetes Clinic, Okazaki East Hospital

Okazaki, Aichi-ken, 444-0008, Japan

RECRUITING

Diabetes Center, Yokkaichi Social Insurance Hospital

Yokkaichi, Mie-ken, 510-0016, Japan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Interventions

alogliptinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Takahiro Tosaki, MD, PhD

    Aichi Gakuin University

    STUDY CHAIR

Central Study Contacts

Takahiro Tosaki, MD, PhD

CONTACT

+81-52-759-2111nrd49075@nifty.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 24, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

JP(4)