Effects of Alogliptin on Pancreatic Beta Cell Function
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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 | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Alogliptin Drug: Metformin 750 mg |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 80 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Alogliptin
Alogliptin 25 mg
|
Drug: Alogliptin
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
|
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| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Takahiro Tosaki, MD, PhD | +81-52-759-2111 | nrd49075@nifty.com |
| Japan | |
| Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University | Recruiting |
| Nagoya, Aichi, Japan, 464-8650 | |
| Contact: Takahiro Tosaki, MD, PhD +81-52-759-2111 nrd49075@nifty.com | |
| Principal Investigator: Takahiro Tosaki, MD, PhD | |
| Sub-Investigator: Keiko Naruse, MD, PhD | |
| Tosaki Clinic for Diabetes and Endocrinology | Not yet recruiting |
| Nagoya, Aichi, Japan, 468-0009 | |
| Contact: Takahiro Tosaki, MD, PhD nrd49075@nifty.com | |
| Principal Investigator: Takahiro Tosaki, MD, PhD | |
| Diabetes Clinic, Okazaki East Hospital | Recruiting |
| Okazaki, Aichi, Japan, 444-0008 | |
| Contact: Takahiro Tosaki, MD, PhD +81-564-22-6616 nrd49075@nifty.com | |
| Sub-Investigator: Chizuko Suzuki, MD, PhD | |
| Sub-Investigator: Maiko Mizutani, MD, PhD | |
| Principal Investigator: Takahiro Tosaki, MD, PhD | |
| Diabetes Center, Yokkaichi Social Insurance Hospital | Recruiting |
| Yokkaichi, Mie, Japan, 510-0016 | |
| Contact: Takahiro Tosaki, MD, PhD +81-59-331-2000 nrd49075@nifty.com | |
| Sub-Investigator: Miho Miyoshi, MD | |
| Sub-Investigator: Tomoki Majima, MD | |
| Principal Investigator: Takahiro Tosaki, MD, PhD | |
| Study Chair: | Takahiro Tosaki, MD, PhD | Aichi Gakuin University |
More Information
No publications provided
| Responsible Party: | Takahiro Tosaki, Aichi Gakuin University |
| ClinicalTrials.gov Identifier: | NCT01303055 History of Changes |
| Other Study ID Numbers: | AGU-248 |
| Study First Received: | February 23, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Aichi Gakuin University:
|
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 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Alogliptin Hypoglycemic Agents |
Metformin Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013