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Effects of Alogliptin on Pancreatic Beta Cell Function

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ClinicalTrials.gov Identifier: NCT01303055
Recruitment Status : Unknown
Verified February 2011 by Aichi Gakuin University.
Recruitment status was:  Recruiting
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
Aichi Gakuin University

February 23, 2011
February 24, 2011
February 24, 2011
February 2011
December 2013   (Final data collection date for primary outcome measure)
beta cell function evaluated from 75 g OGTT [ Time Frame: 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.

Same as current
No Changes Posted
1,5-AG level [ Time Frame: 2 years ]
Secondary end points include HbA1c level.
Same as current
Not Provided
Not Provided
 
Effects of Alogliptin on Pancreatic Beta Cell Function
Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Alogliptin
    Alogliptin 25 mg, tablets, orally, once daily : two years
    Other Name: Nothing
  • 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
  • Experimental: Alogliptin
    Alogliptin 25 mg
    Intervention: Drug: Alogliptin
  • Active Comparator: Metformin
    Metformin 750 mg
    Intervention: Drug: Metformin 750 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
Same as current
December 2014
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01303055
AGU-248
Yes
Not Provided
Not Provided
Takahiro Tosaki, Aichi Gakuin University
Aichi Gakuin University
Not Provided
Study Chair: Takahiro Tosaki, MD, PhD Aichi Gakuin University
Aichi Gakuin University
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP