Clinical trial NCT01303055: Effects of Alogliptin on Pancreatic Beta Cell Function
Official title: Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Aichi Gakuin University
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: beta cell function evaluated from 75 g OGTT
timeFrame: 2 years
Secondary outcomes:
measure: 1,5-AG level
timeFrame: 2 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
state: Aichi
city: Nagoya
country: Japan
facility: Tosaki Clinic for Diabetes and Endocrinology
state: Aichi
city: Okazaki
country: Japan
facility: Diabetes Clinic, Okazaki East Hospital
state: Aichi
city: Yokkaichi
country: Japan
facility: Diabetes Center, Yokkaichi Social Insurance Hospital
state: Mie
Study officials:
affiliation: Aichi Gakuin University
name: Takahiro Tosaki, MD, PhD
role: STUDY_CHAIR
References: