Effects of Alogliptin on Pancreatic Beta Cell Function
Overview[ - collapse ][ - ]
| 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 | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Alogliptin Drug: Metformin 750 mg |
| Phase | N/A |
| Sponsor | Aichi Gakuin University |
| Responsible Party | Aichi Gakuin University |
| ClinicalTrials.gov Identifier | NCT01303055 |
| First Received | February 23, 2011 |
| Last Updated | February 23, 2011 |
| Last verified | February 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 23, 2011 |
|---|---|
| Last Updated Date | February 23, 2011 |
| Start Date | February 2011 |
| Estimated Primary Completion Date | December 2014 |
| Current 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. |
| Current Secondary Outcome Measures | 1,5-AG level [Time Frame: 2 years] [Designated as safety issue: Yes]Secondary end points include HbA1c level. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effects of Alogliptin on Pancreatic Beta Cell Function |
|---|---|
| Official Title | Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function |
| 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Alogliptin Alogliptin 25 mg, tablets, orally, once daily : two years Other Names: NothingDrug: 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 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 80 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | December 2013 |
| 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 |
| Gender | Both |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Takahiro Tosaki, MD, PhD +81-52-759-2111 nrd49075@nifty.com |
| Location Countries | Japan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01303055 |
|---|---|
| Other Study ID Numbers | AGU-248 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Aichi Gakuin University |
| Study Sponsor | Aichi Gakuin University |
| Collaborators | Not Provided |
| Investigators | Study Chair: Takahiro Tosaki, MD, PhD Aichi Gakuin University |
| Verification Date | February 2011 |
Locations[ + expand ][ + ]
| Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University | Nagoya, Aichi, Japan, 464-8650 Contact: Takahiro Tosaki, MD, PhD | +81-52-759-2111 | nrd49075@nifty.comPrincipal Investigator: Takahiro Tosaki, MD, PhD Recruiting |
|---|---|
| Tosaki Clinic for Diabetes and Endocrinology | Nagoya, Aichi, Japan, 468-0009 Contact: Takahiro Tosaki, MD, PhD | nrd49075@nifty.comPrincipal Investigator: Takahiro Tosaki, MD, PhD Not yet recruiting |
| Diabetes Clinic, Okazaki East Hospital | Okazaki, Aichi, Japan, 444-0008 Contact: Takahiro Tosaki, MD, PhD | +81-564-22-6616 | nrd49075@nifty.comSub-Investigator: Chizuko Suzuki, MD, PhD Recruiting |
| Diabetes Center, Yokkaichi Social Insurance Hospital | Yokkaichi, Mie, Japan, 510-0016 Contact: Takahiro Tosaki, MD, PhD | +81-59-331-2000 | nrd49075@nifty.comSub-Investigator: Miho Miyoshi, MD Recruiting |