Diabetes Mellitus, Type 2NCT01303055
Effects of Alogliptin on Pancreatic Beta Cell Function
A study testing Alogliptin and Metformin 750 mg in people with Diabetes Mellitus, Type 2, run by Aichi Gakuin University at 4 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Alogliptin and Metformin 750 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesJapan
- Study dates
- Feb 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Japan4 sites, 4 recruiting
- Recruiting
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
Nagoya, Aichi-ken, 464-8650
Takahiro Tosaki, MD, PhD, +81-52-759-2111, nrd49075@nifty.com
Takahiro Tosaki, MD, PhD
- Not yet recruiting
Tosaki Clinic for Diabetes and Endocrinology
Nagoya, Aichi-ken, 468-0009
Takahiro Tosaki, MD, PhD, nrd49075@nifty.com
Takahiro Tosaki, MD, PhD
- Recruiting
Diabetes Clinic, Okazaki East Hospital
Okazaki, Aichi-ken, 444-0008
Takahiro Tosaki, MD, PhD, +81-564-22-6616, nrd49075@nifty.com
Chizuko Suzuki, MD, PhD
- Recruiting
Diabetes Center, Yokkaichi Social Insurance Hospital
Yokkaichi, Mie-ken, 510-0016
Takahiro Tosaki, MD, PhD, +81-59-331-2000, nrd49075@nifty.com
Miho Miyoshi, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Alogliptin, Metformin 750 mg
- Keywords
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlogliptinDrug
Also called Nothing
Alogliptin 25 mg, tablets, orally, once daily : two years
Metformin 750 mgDrug
Also called Nothing
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 %.
| Study group | Role | What they receive |
|---|---|---|
| Alogliptin | Experimental | Alogliptin 25 mg Receives: Drug: Alogliptin |
| Metformin | Active comparator | Metformin 750 mg Receives: Drug: Metformin 750 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
beta cell function evaluated from 75 g OGTT
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.
Measured: 2 years
Secondary outcomes (1)
1,5-AG level
Secondary end points include HbA1c level.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aichi Gakuin University
- Sponsor type
- University, hospital or other
- Investigators
- Takahiro Tosaki, MD, PhD, Study chair, Aichi Gakuin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303055
- Sponsor's protocol ID
- AGU-248
- Status last verified
- Feb 2011
- First submitted
- 23 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function
- ClinicalTrials.gov ID
- NCT01303055
- Acronym / sponsor ID
- AGU-248
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Pancreatic beta Cell, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Metformin, Hypoglycemic Agents, Physiological Effects of Drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aichi Gakuin UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alogliptin | Experimental | Drug: AlogliptinAlogliptin 25 mg |
| Metformin | Active comparator | Drug: Metformin 750 mgMetformin 750 mg |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlogliptinAlso: NothingAlogliptin 25 mg, tablets, orally, once daily : two years | Drug | Alogliptin |
| Metformin 750 mgAlso: NothingMetformin 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 %. | Drug | Metformin |
Primary outcome
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.
1 secondary outcome
1,5-AG level
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takahiro Tosaki, MD, PhD study chair
Aichi Gakuin University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alogliptin and Metformin 750 mg in people with Diabetes Mellitus, Type 2, run by Aichi Gakuin University at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takahiro Tosaki, MD, PhD (+81-52-759-2111, nrd49075@nifty.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
beta cell function evaluated from 75 g OGTT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011.