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Diabetes MellitusPhase 3NCT00306384

Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Alogliptin in people with Diabetes Mellitus, run by Takeda at 114 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Alogliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,323 participants
Where
114 sitesin 12 countries
Study dates
Mar 2006to Nov 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Type 2 diabetes mellitus and was enrolled in one of the following 7 controlled Phase III studies. The study will be open to all patients who completed one of these studies through the end-of-treatment visit:
  • SYR-322-PLC-010 - NCT00286455
  • SYR-322-SULF-007 - NCT00286468
  • SYR-322-MET-008 - NCT00286442
  • SYR-322-TZD-009 - NCT00286494
Show all 12Show fewer
  • SYR-322-INS-011 - NCT00286429
  • 01-05-TL-322OPI-001 - NCT00328627
  • 01-06-TL-322OPI-002 - NCT00395512
  • Alanine aminotransferase less than or equal to 3 times the upper limit of normal and serum creatinine less than or equal to 2.0 mg per dL.
  • Able and willing to monitor own blood glucose concentrations with a home glucose monitor.
  • No major illness or debility that in the investigator's opinion prohibits the patient from completing the study.

Who cannot join

  • The occurrence of any adverse event or condition during the controlled Phase III studies, which, in the opinion of the investigator, should exclude the patient from participating in the open-label extension.
  • Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • Weight-loss drugs
  • Investigational antidiabetics, additional dipeptidyl peptidase-4 (DPP-4) and glucagon-like peptide-1 (GLP 1) inhibitors
  • Incretin Mimetics,
  • Oral or systemically injected glucocorticoids.

Trial locations and contacts

114 sites in 12 countries.

114 sites in 12 countries

United States62 sites

  • Study site

    Anaheim, California

  • Study site

    Artesia, California

  • Study site

    Avon, Indiana

  • Study site

    Baltimore, Maryland

  • Study site

    Berlin, New Jersey

  • Study site

    Birmingham, Alabama

  • Study site

    Bristol, Tennessee

  • Study site

    Burlington, North Carolina

  • Study site

    Burlington, Vermont

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chesterfield, Missouri

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnatti, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, South Carolina

  • Study site

    Cookeville, Tennessee

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Elkhart, Indiana

  • Study site

    Erlanger, Kentucky

  • Study site

    Evansville, Indiana

  • Study site

    Fresno, California

  • Study site

    Hollywood, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Idaho Falls, Idaho

  • Study site

    Kissimmee, Florida

  • Study site

    Lafayette, Indiana

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Lawrenceville, Georgia

  • Study site

    Longwood, Florida

  • Study site

    Los Angeles, California

  • Study site

    Medford, Oregon

  • Study site

    Milan, Tennessee

  • Study site

    Mission Viejo, California

  • Study site

    Morehead City, North Carolina

  • Study site

    New Port Richie, Florida

  • Study site

    Northridge, California

  • Study site

    Norwalk, Connecticut

  • Study site

    Ocala, Florida

  • Study site

    Ocoee, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Peoria, Arizona

  • Study site

    Phoenix, Arizona

  • Study site

    Pinehurst, North Carolina

  • Study site

    Saint Cloud, Florida

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Simpsonville, South Carolina

  • Study site

    St Louis, Missouri

  • Study site

    Sudbury, Massachusetts

  • Study site

    Temple, Texas

  • Study site

    Texarkana, Texas

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tustin, California

  • Study site

    Walnut Creek, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Grove, Pennsylvania

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Germany10 sites

  • Study site

    Aschaffenburg

  • Study site

    Berlin

  • Study site

    Frankfurt

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Munich

  • Study site

    Nuremberg

  • Study site

    Schwerin

  • Study site

    Wiesbaden

  • Study site

    Witten

Other trials in Germany

Argentina7 sites

  • Study site

    Buenos Aires, La Plata

  • Study site

    Buenos Aires, Moron

  • Study site

    Buenos Aires

  • Study site

    Ciudadd Autonoma de Buenos Aires

  • Study site

    Córdoba

  • Study site

    Mar del Plata

  • Study site

    Rosario, Sante Fe

Other trials in Argentina

Brazil6 sites

  • Study site

    Curitiba, Paraná

  • Study site

    Fortaleza, Ceará

  • Study site

    Mogi das Cruzes, São Paulo

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Santos, São Paulo

  • Study site

    São Paulo

Other trials in Brazil

Netherlands6 sites

  • Study site

    Almere Stad

  • Study site

    De Bilt

  • Study site

    Geleen

  • Study site

    Oud-Beijerland

  • Study site

    Rotterdam

  • Study site

    Zwijndrecht

Other trials in Netherlands

Poland6 sites

  • Study site

    Bytom

  • Study site

    Kamieniec Ząbkowicki

  • Study site

    Krakow

  • Study site

    Łęczyca

  • Study site

    Lodz

  • Study site

    Radom

Other trials in Poland

South Africa6 sites

  • Study site

    Cape Town, Western Cape

  • Study site

    Durban

  • Study site

    Johannesburg

  • Study site

    Parow

  • Study site

    Pretoria, Gauteng

  • Study site

    Somerset West, Western Cape

Other trials in South Africa

Czechia4 sites

  • Study site

    Ostrava

  • Study site

    Prague

  • Study site

    Sternberk

  • Study site

    Zlín

Other trials in Czechia

Peru4 sites

  • Study site

    Bellavista, Lima region

  • Study site

    Ica

  • Study site

    Lima

  • Study site

    San Isidro, Lima region

Other trials in Peru

Chile1 site

  • Study site

    Santiago

Other trials in Chile

Dominican Republic1 site

  • Study site

    Santo Domingo Oeste

Other trials in Dominican Republic

Guatemala1 site

  • Study site

    Guatemala City

Other trials in Guatemala

About this study

Official title: A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.

Read the detailed description

SYR-322 (alogliptin) is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes mellitus by prolonging the beneficial effects of glucagon-like peptide-1.

The rising incidence of type 2 diabetes mellitus and the limitations of the currently available treatments suggest the need for new therapies for glycemic control. Studies have been undertaken in humans that evaluated the effects of directly augmenting glucagon-like peptide-1 and glucose-dependent insulinotropic peptide levels and of inhibiting the activity of dipeptidyl peptidase IV.

This study is an extension of 7 controlled phase 3 studies of alogliptin. These phase 3 studies included 1 monotherapy study of alogliptin (SYR-322-PLC-010; NCT00286455); 4 placebo-controlled add-on studies of alogliptin, namely in combination with a sulfonylurea (SYR-322-SULF-007; NCT00286468), metformin (SYR-322-MET-008; NCT00286442), a thiazolidinedione (pioglitazone; SYR-322-TZD-009; NCT00286494), and insulin (SYR-322-INS-011; NCT00286429); 1 coadministration study with pioglitazone in combination with metformin (01-05-TL-322OPI-001; NCT00328627), and 1 coadministration study with pioglitazone (01-06-TL-322OPI-002; NCT00395512).

The end of treatment or early withdrawal visit from the preceding study will be the screening visit for this study, after which enrolled patients will be required to commit to approximately 22 additional visits at the study center.

Being tested
Alogliptin
Keywords
Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus,, Lipoatrophic, Dyslipidemia, Drug Therapy
Medical subject headings
Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlogliptinDrug

    Also called SYR110322, SYR-322

    Alogliptin tablets.

Study groups in NCT00306384
Study groupRoleWhat they receive
Alogliptin 12.5 mgExperimentalAlogliptin 12.5 tablet, orally, once daily for up to 4 years.
Receives: Drug: Alogliptin
Alogliptin 25 mgExperimentalAlogliptin 25 mg tablet, orally, once daily for up to 4 years.
Receives: Drug: Alogliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.

    Measured: 4 years

Secondary outcomes (8)

  1. Change From Baseline Over Time in Glycosylated Hemoglobin

    The change from Baseline in glycosylated hemoglobin (HbA1c; the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Endpoint was defined as the last postbaseline observation collected within 7 days after the last dose of open-label study drug.

    Measured: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42 and 45.

  2. Change From Baseline in Fasting Plasma Glucose

    The change from Baseline in fasting plasma glucose (FPG) at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.

    Measured: Baseline and Year 4

  3. Percentage of Participants With Marked Hyperglycemia

    Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (≥11.10 mmol/L).

    The Month 42 to Month 45 interval includes all marked hyperglycemic episodes occurring on or after Day 1247 (a 203-day visit window).

    Measured: Randomization up to 4 years.

  4. Change From Baseline in Proinsulin Level

    Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.

    Note: A transcription error occurred in the reporting of 1 proinsulin value for a patient in the alogliptin 25 mg completed group, for whom a partial patient ID number was mistakenly entered as an end-of-treatment proinsulin level.

    Measured: Baseline and Year 4

  5. Change From Baseline in Insulin Level

    The change from Baseline in fasting insulin at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.

    Measured: Baseline and Year 4

  6. Change From Baseline in C-peptide Level

    C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.

    Measured: Baseline and Year 4

  7. Change From Baseline in Body Weight

    Change from Baseline in body weight to the last post-baseline observation collected within 7 days after the last dose of open-label study drug.

    Measured: Baseline and Year 4

  8. Percentage of Participants With a Clinical Response

    Clinical response was defined based on the absolute value of HbA1c meeting one of two clinical targets at any post-baseline visit:

    • HbA1c ≤6.5%;
    • HbA1c ≤7.0%.

    Measured: Weeks 2, 4, 8, 12, every 3 months up to 4 years, and 1 Day after final dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00306384
Sponsor's protocol ID
SYR-322-OLE-012
Other IDs
2005-004672-20, U1111-1113-8455, 2005
Status last verified
Feb 2013
First submitted
21 Mar 2006
Last updated
22 Mar 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alogliptin in people with Diabetes Mellitus, run by Takeda at 114 sites in 12 countries.

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 12 inclusion and 6 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: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Germany, Argentina, Brazil, Netherlands and 7 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00306384.

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 22 Mar 2013.

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Clinical Trial NCT00306384 | AzTrials