Effects of Alogliptin on Pancreatic Beta Cell Function
Recruitment status was: Recruiting
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.
|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|
- 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.
- 1,5-AG level [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Secondary end points include HbA1c level.
|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)|
Alogliptin 25 mg
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303055
|Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University|
|Nagoya, Aichi, Japan, 464-8650|
|Tosaki Clinic for Diabetes and Endocrinology|
|Nagoya, Aichi, Japan, 468-0009|
|Diabetes Clinic, Okazaki East Hospital|
|Okazaki, Aichi, Japan, 444-0008|
|Diabetes Center, Yokkaichi Social Insurance Hospital|
|Yokkaichi, Mie, Japan, 510-0016|
|Study Chair:||Takahiro Tosaki, MD, PhD||Aichi Gakuin University|