Effects of Alogliptin on Pancreatic Beta Cell Function

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01303055
• Other study ID #: AGU-248
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2011
• Last updated: February 23, 2011
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2011
• Source: Aichi Gakuin University
• Contact: Takahiro Tosaki, MD, PhD
• Phone: +81-52-759-2111
• Email: nrd49075[@]nifty.com
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Alogliptin
Alogliptin 25 mg, tablets, orally, once daily : two years
• 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 %.

Locations

Country	Name	City	State
Japan	Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University	Nagoya	Aichi
Japan	Tosaki Clinic for Diabetes and Endocrinology	Nagoya	Aichi
Japan	Diabetes Clinic, Okazaki East Hospital	Okazaki	Aichi
Japan	Diabetes Center, Yokkaichi Social Insurance Hospital	Yokkaichi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Aichi Gakuin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	1,5-AG level	Secondary end points include HbA1c level.	2 years	Yes