Effects of Alogliptin on Pancreatic Beta Cell Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Aichi Gakuin University
Sponsor:
Information provided by:
Aichi Gakuin University
ClinicalTrials.gov Identifier:
NCT01303055
First received: February 23, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Alogliptin
Drug: Metformin 750 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function

Resource links provided by NLM:


Further study details as provided by Aichi Gakuin University:

Primary Outcome Measures:
  • beta cell function evaluated from 75 g OGTT [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Secondary end points include HbA1c level.


Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alogliptin
Alogliptin 25 mg
Drug: Alogliptin
Alogliptin 25 mg, tablets, orally, once daily : two years
Other Name: 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 Name: Nothing

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303055

Contacts
Contact: Takahiro Tosaki, MD, PhD +81-52-759-2111 nrd49075@nifty.com

Locations
Japan
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University Recruiting
Nagoya, Aichi, Japan, 464-8650
Contact: Takahiro Tosaki, MD, PhD    +81-52-759-2111    nrd49075@nifty.com   
Principal Investigator: Takahiro Tosaki, MD, PhD         
Sub-Investigator: Keiko Naruse, MD, PhD         
Tosaki Clinic for Diabetes and Endocrinology Not yet recruiting
Nagoya, Aichi, Japan, 468-0009
Contact: Takahiro Tosaki, MD, PhD       nrd49075@nifty.com   
Principal Investigator: Takahiro Tosaki, MD, PhD         
Diabetes Clinic, Okazaki East Hospital Recruiting
Okazaki, Aichi, Japan, 444-0008
Contact: Takahiro Tosaki, MD, PhD    +81-564-22-6616    nrd49075@nifty.com   
Sub-Investigator: Chizuko Suzuki, MD, PhD         
Sub-Investigator: Maiko Mizutani, MD, PhD         
Principal Investigator: Takahiro Tosaki, MD, PhD         
Diabetes Center, Yokkaichi Social Insurance Hospital Recruiting
Yokkaichi, Mie, Japan, 510-0016
Contact: Takahiro Tosaki, MD, PhD    +81-59-331-2000    nrd49075@nifty.com   
Sub-Investigator: Miho Miyoshi, MD         
Sub-Investigator: Tomoki Majima, MD         
Principal Investigator: Takahiro Tosaki, MD, PhD         
Sponsors and Collaborators
Aichi Gakuin University
Investigators
Study Chair: Takahiro Tosaki, MD, PhD Aichi Gakuin University
  More Information

No publications provided

Responsible Party: Takahiro Tosaki, Aichi Gakuin University
ClinicalTrials.gov Identifier: NCT01303055     History of Changes
Other Study ID Numbers: AGU-248
Study First Received: February 23, 2011
Last Updated: February 23, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Aichi Gakuin University:
Endocrine System Diseases
Pancreatic beta Cell
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
hemoglobin A1c protein, human
Oral Glucose Tolerance Test

Additional relevant MeSH terms:
Endocrine System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Alogliptin
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014