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

NCT00306384 | Completed Phase 3 Results

• 3 other identifiers: SYR-322-OLE-0122005-004672-20U1111-1113-8455
• Study Type: interventional
• Target: 3,323
• Locations: 12 countries
• Sites: 114

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus,; Lipoatrophic; Dyslipidemia; Drug Therapy

Outcome Measures

Primary Outcomes (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.

  4 years

Secondary Outcomes (8)

• Change From Baseline Over Time in Glycosylated Hemoglobin

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

• Change From Baseline in Fasting Plasma Glucose

  Baseline and Year 4

• Percentage of Participants With Marked Hyperglycemia

  Randomization up to 4 years.

• Change From Baseline in Proinsulin Level

  Baseline and Year 4

• Change From Baseline in Insulin Level

  Baseline and Year 4

Study Arms (2)

Alogliptin 12.5 mg

EXPERIMENTAL

Alogliptin 12.5 tablet, orally, once daily for up to 4 years.

Drug: Alogliptin

Alogliptin 25 mg

EXPERIMENTAL

Alogliptin 25 mg tablet, orally, once daily for up to 4 years.

Drug: Alogliptin

Interventions

Alogliptin DRUG

Alogliptin tablets.

Also known as: SYR110322, SYR-322

Alogliptin 12.5 mg; Alogliptin 25 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• SYR-322-INS-011 - NCT00286429
• TL-322OPI-001 - NCT00328627
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (114)

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Birmingham, Alabama, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Artesia, California, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Northridge, California, United States

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Orange, California, United States

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San Diego, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Norwalk, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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Hollywood, Florida, United States

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Kissimmee, Florida, United States

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Longwood, Florida, United States

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New Port Richie, Florida, United States

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Ocala, Florida, United States

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Ocoee, Florida, United States

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Saint Cloud, Florida, United States

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Lawrenceville, Georgia, United States

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Honolulu, Hawaii, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Lafayette, Indiana, United States

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Erlanger, Kentucky, United States

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Baltimore, Maryland, United States

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Sudbury, Massachusetts, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Berlin, New Jersey, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Morehead City, North Carolina, United States

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Pinehurst, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnatti, Ohio, United States

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Dayton, Ohio, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Lansdale, Pennsylvania, United States

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West Grove, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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Cookeville, Tennessee, United States

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Milan, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Texarkana, Texas, United States

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Burlington, Vermont, United States

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Buenos Aires, La Plata, Argentina

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Buenos Aires, Moron, Argentina

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Rosario, Sante Fe, Argentina

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Buenos Aires, Argentina

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Ciudadd Autonoma de Buenos Aires, Argentina

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Córdoba, Argentina

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Mar del Plata, Argentina

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Fortaleza, Ceará, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Mogi das Cruzes, São Paulo, Brazil

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Santos, São Paulo, Brazil

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São Paulo, Brazil

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Santiago, Chile

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Ostrava, Czechia

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Prague, Czechia

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Sternberk, Czechia

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Zlín, Czechia

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Santo Domingo Oeste, Dominican Republic

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Aschaffenburg, Germany

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Berlin, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Hanover, Germany

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Munich, Germany

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Nuremberg, Germany

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Schwerin, Germany

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Wiesbaden, Germany

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Witten, Germany

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Guatemala City, Guatemala

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Almere Stad, Netherlands

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De Bilt, Netherlands

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Geleen, Netherlands

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Oud-Beijerland, Netherlands

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Rotterdam, Netherlands

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Zwijndrecht, Netherlands

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Bellavista, Lima region, Peru

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San Isidro, Lima region, Peru

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Ica, Peru

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Lima, Peru

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Bytom, Poland

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Kamieniec Ząbkowicki, Poland

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Krakow, Poland

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Lodz, Poland

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Radom, Poland

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Łęczyca, Poland

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Pretoria, Gauteng, South Africa

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Cape Town, Western Cape, South Africa

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Somerset West, Western Cape, South Africa

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Durban, South Africa

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Johannesburg, South Africa

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Parow, South Africa

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MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

alogliptin

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• VP Biological Sciences

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 23, 2006
• Study Start: March 1, 2006
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 22, 2013
• Results First Posted: March 22, 2013

Record last verified: 2013-02

Locations

CL (1); NL (6); BR (6); US (62); CZ (4); GU (1); PE (4); PL (6); DE (10); DO (1); ZA (6); AR (7)