Effects of Alogliptin on Pancreatic Beta Cell Function

Sponsor

Aichi Gakuin University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01303055

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Alogliptin Drug: Metformin 750 mg	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function

Study Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alogliptin Alogliptin 25 mg	Drug: Alogliptin Alogliptin 25 mg, tablets, orally, once daily : two years Other Names: 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 Names: Nothing

Arm

Intervention/Treatment

Experimental: Alogliptin

Alogliptin 25 mg

Drug: Alogliptin

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

Other Names:

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 Names:

Nothing

Outcome Measures

Primary Outcome Measures

beta cell function evaluated from 75 g OGTT [2 years]
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 [2 years]
Secondary end points include HbA1c level.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University	Nagoya	Aichi	Japan	464-8650
2	Tosaki Clinic for Diabetes and Endocrinology	Nagoya	Aichi	Japan	468-0009
3	Diabetes Clinic, Okazaki East Hospital	Okazaki	Aichi	Japan	444-0008
4	Diabetes Center, Yokkaichi Social Insurance Hospital	Yokkaichi	Mie	Japan	510-0016