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Effects of Alogliptin on Pancreatic Beta Cell Function

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Alogliptin
Metformin 750 mg
Sponsored by
Aichi Gakuin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Pancreatic beta Cell, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Metformin, Hypoglycemic Agents, Physiological Effects of Drugs, Pharmacologic Actions, hemoglobin A1c protein, human, Oral Glucose Tolerance Test

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Intern. Med., School of Dentistry, Aichi Gakuin UniversityRecruiting
  • Tosaki Clinic for Diabetes and Endocrinology
  • Diabetes Clinic, Okazaki East HospitalRecruiting
  • Diabetes Center, Yokkaichi Social Insurance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alogliptin

Metformin

Arm Description

Alogliptin 25 mg

Metformin 750 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

1,5-AG level
Secondary end points include HbA1c level.

Full Information

First Posted
February 23, 2011
Last Updated
February 23, 2011
Sponsor
Aichi Gakuin University
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1. Study Identification

Unique Protocol Identification Number
NCT01303055
Brief Title
Effects of Alogliptin on Pancreatic Beta Cell Function
Official Title
Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Aichi Gakuin University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Pancreatic beta Cell, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Metformin, Hypoglycemic Agents, Physiological Effects of Drugs, Pharmacologic Actions, hemoglobin A1c protein, human, Oral Glucose Tolerance Test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alogliptin
Arm Type
Experimental
Arm Description
Alogliptin 25 mg
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin 750 mg
Intervention Type
Drug
Intervention Name(s)
Alogliptin
Other Intervention Name(s)
Nothing
Intervention Description
Alogliptin 25 mg, tablets, orally, once daily : two years
Intervention Type
Drug
Intervention Name(s)
Metformin 750 mg
Other Intervention Name(s)
Nothing
Intervention Description
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 %.
Primary Outcome Measure Information:
Title
beta cell function evaluated from 75 g OGTT
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
1,5-AG level
Description
Secondary end points include HbA1c level.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takahiro Tosaki, MD, PhD
Phone
+81-52-759-2111
Email
nrd49075@nifty.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD
Organizational Affiliation
Aichi Gakuin University
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8650
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD
Phone
+81-52-759-2111
Email
nrd49075@nifty.com
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD
First Name & Middle Initial & Last Name & Degree
Keiko Naruse, MD, PhD
Facility Name
Tosaki Clinic for Diabetes and Endocrinology
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
468-0009
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD
Email
nrd49075@nifty.com
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD
Facility Name
Diabetes Clinic, Okazaki East Hospital
City
Okazaki
State/Province
Aichi
ZIP/Postal Code
444-0008
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD
Phone
+81-564-22-6616
Email
nrd49075@nifty.com
First Name & Middle Initial & Last Name & Degree
Chizuko Suzuki, MD, PhD
First Name & Middle Initial & Last Name & Degree
Maiko Mizutani, MD, PhD
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD
Facility Name
Diabetes Center, Yokkaichi Social Insurance Hospital
City
Yokkaichi
State/Province
Mie
ZIP/Postal Code
510-0016
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD
Phone
+81-59-331-2000
Email
nrd49075@nifty.com
First Name & Middle Initial & Last Name & Degree
Miho Miyoshi, MD
First Name & Middle Initial & Last Name & Degree
Tomoki Majima, MD
First Name & Middle Initial & Last Name & Degree
Takahiro Tosaki, MD, PhD

12. IPD Sharing Statement

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Effects of Alogliptin on Pancreatic Beta Cell Function

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