Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus

NCT00395512 | Completed Phase 3 Results

• 3 other identifiers: 01-06-TL-322OPI-0022006-005492-17U1111-1113-8616
• Study Type: interventional
• Target: 655
• Locations: 23 countries
• Sites: 161

Brief Summary

The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone.

Conditions

Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)

  The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).

  Baseline and Week 26

Secondary Outcomes (40)

• Change From Baseline in HbA1c Over Time

  Baseline and Weeks 4, 8, 12, 16 and 20.

• Change From Baseline in Fasting Plasma Glucose Over Time

  Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.

• Percentage of Participants With Marked Hyperglycemia

  Weeks 1, 2, 4, 8, 12, 16, 20 and 26.

• Percentage of Participants Meeting Rescue Criteria

  Weeks 4, 8, 12, 16, 20 and 26.

• Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%

  Week 26

Study Arms (4)

Alogliptin 25 mg QD

EXPERIMENTAL

Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.

Drug: Alogliptin; Drug: Placebo

Pioglitazone 30 mg QD

ACTIVE COMPARATOR

Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.

Drug: Pioglitazone; Drug: Placebo

Alogliptin 25 mg QD+ Pioglitazone 30 mg QD

EXPERIMENTAL

Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.

Drug: Alogliptin; Drug: Pioglitazone

Alogliptin 12.5 mg QD + Pioglitazone 30 mg QD

ACTIVE COMPARATOR

Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.

Drug: Alogliptin; Drug: Pioglitazone

Interventions

Alogliptin DRUG

Alogliptin tablets.

Also known as: SYR-322

Alogliptin 12.5 mg QD + Pioglitazone 30 mg QD; Alogliptin 25 mg QD; Alogliptin 25 mg QD+ Pioglitazone 30 mg QD

Pioglitazone DRUG

Pioglitazone tablets.

Also known as: Actos, AD4833

Alogliptin 12.5 mg QD + Pioglitazone 30 mg QD; Alogliptin 25 mg QD+ Pioglitazone 30 mg QD; Pioglitazone 30 mg QD

Placebo DRUG

Matching placebo tablets.

Alogliptin 25 mg QD; Pioglitazone 30 mg QD

Eligibility Criteria

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

You may qualify if:

• Historical diagnosis of type 2 diabetes.
• Failed treatment with diet and exercise for at least 2 months prior to Screening.
• Is experiencing inadequate glycemic control as defined as glycosylated hemoglobin concentration between 7.5-11%, inclusive.
• Has received any antidiabetic therapy for less than 7 days within 3 months prior to Screening.
• Has a body mass index greater than or equal to 23 kg/m2 and less than or equal to45 kg/m2.
• Fasting C-peptide greater than or equal to 0.8 ng per mL.
• Regular use of other, non-excluded medications is allowed if participant is on a stable dose for at least 4 weeks prior to Screening.
• 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.
• Must be willing and able to monitor their blood concentrations with a home glucose monitor.

You may not qualify if:

• Systolic blood pressure greater than or equal to 160 mmHg and diastolic blood pressure greater than or equal to 100 mmHg.
• Hemoglobin less than or equal to 12 g per dL for males and less than or equal to 10 g per dL for females.
• Alanine aminotransferase greater than or equal to 2.5times the upper limit of normal.
• Serum creatinine greater than 2.0 mg per dL.
• Thyroid stimulating hormone level greater than the upper limit of normal range.
• Major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
• Urine albumin to creatinine ratio of greater than 1000 ug per mg at Screening. If elevated, the subject may be rescreened within 1 week.
• History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening
• History of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• History of gastroparesis.
• Has New York Heart Association Class I to IV heart failure regardless of therapy.
• History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
• History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
• History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• History of a psychiatric disorder that will affect participant's ability to participate in the study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (161)

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Columbiana, Alabama, United States

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Hueytown, Alabama, United States

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Huntsville, Alabama, United States

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Northport, Alabama, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Searcy, Arkansas, United States

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Foothill Ranch, California, United States

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Irvine, California, United States

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Northridge, California, United States

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San Diego, California, United States

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San Mateo, California, United States

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Santa Monica, California, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Port Charlotte, Florida, United States

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Sebastian, Florida, United States

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South Miami, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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Barnesville, Georgia, United States

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Columbus, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Libertyville, Illinois, United States

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South Bend, Indiana, United States

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Bossier City, Louisiana, United States

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Elkton, Maryland, United States

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Prince Frederick, Maryland, United States

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Towson, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Bay City, Michigan, United States

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Benzonia, Michigan, United States

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Portage, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Picayune, Mississippi, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Las Vegas, Nevada, United States

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Elizabeth, New Jersey, United States

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Hamilton, New Jersey, United States

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Cicero, New York, United States

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Charlotte, North Carolina, United States

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Mooresville, North Carolina, United States

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Northeast, North Dakota, United States

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Franklin, Ohio, United States

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Ashland, Oregon, United States

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Altoona, Pennsylvania, United States

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Fleetwood, Pennsylvania, United States

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Harleysville, Pennsylvania, United States

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Havertown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Northern Cambria, Pennsylvania, United States

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Penndel, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Florence, South Carolina, United States

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Orangeburg, South Carolina, United States

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Taylors, South Carolina, United States

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Williamston, South Carolina, United States

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Morristown, Tennessee, United States

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Arlington, Texas, United States

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Colleyville, Texas, United States

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Conroe, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Euless, Texas, United States

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Fort Worth, Texas, United States

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Garland, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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San Antonio, Texas, United States

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Seguin, Texas, United States

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Sugarland, Texas, United States

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Tomball, Texas, United States

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Ogden, Utah, United States

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Arlington, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Lewisburg, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Cap. Fed., Buenos Aires, Argentina

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Chacabuco, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Morón, Buenos Aires, Argentina

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Córdoba, Argentina

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Kingswood, New South Wales, Australia

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Fitzroy, Victoria, Australia

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Frankston, Victoria, Australia

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Fortaleza, Ceará, Brazil

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Goiás, Goiás, Brazil

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Curitiba, Paraná, Brazil

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Belém, Pará, Brazil

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Maringá, RP, Brazil

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Marília, São Paulo, Brazil

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Mogi das Cruzes, São Paulo, Brazil

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Pleven, Bulgaria

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Santiago, Chile

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Slavonski Brod, Croatia

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Pärnu, Estonia

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Guatemala City, Guatemala

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Budapest, Hungary

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Eger, Hungary

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Gyula, Hungary

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Makó, Hungary

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Nyíregyháza, Hungary

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Pécs, Hungary

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Hyderabad, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Aurangabad, Maharashtra, India

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Mumbai, Maharashtra, India

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Nagpur, Maharashtra, India

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Chennai, Tamil Nadu, India

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Hadera, Israel

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Haifa, Israel

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Holon, Israel

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Jaffa Tel Aviv, Israel

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Jerusalem, Israel

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Nahariya, Israel

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Riga, Latvia

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Kaunas, Lithuania

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Kėdainiai, Lithuania

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Aguascalientes, Mexico

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Mexico City, Mexico

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Monterrey, Mexico

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Christchurch, New Zealand

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Hamilton, New Zealand

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Bialystok, Poland

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Bytom, Poland

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Gdansk, Poland

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Gniewkowo, Poland

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Kamieniec Ząbkowicki, Poland

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Krakow, Poland

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Łęczyca, Poland

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Brasov, Romania

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Bucharest, Romania

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Galati, Romania

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Kazan', Russia

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Moscow, Russia

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Yekaterinburg, Russia

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Belgrade, Serbia

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Kragujevac, Serbia

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Niš, Serbia

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Interna Klinika II, Nitra Region, Slovakia

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Banska Bysterica, Slovakia

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Lučenec, Slovakia

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Riverside, Slovakia

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Šahy, Slovakia

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Port Elizabeth, Eastern Cape, South Africa

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Johannesburg, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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East Lynne, Pretoria, South Africa

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Bellville, Western Province, South Africa

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Cape Town, Western Province, South Africa

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Dnipropetrovsk, Ukraine

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Kharkiv, Ukraine

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Lviv, Ukraine

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Odesa, Ukraine

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Related Publications (1)

• Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wilson CA, Mekki Q. Initial combination therapy with alogliptin and pioglitazone in drug-naive patients with type 2 diabetes. Diabetes Care. 2010 Nov;33(11):2406-8. doi: 10.2337/dc10-0159. Epub 2010 Aug 19.

  PMID: 20724648 RESULT

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

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

Interventions

alogliptin; Pioglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 3, 2006
• Study Start: November 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 27, 2013
• Results First Posted: March 27, 2013

Record last verified: 2013-02

Locations

HU (6); UA (4); PL (7); LA (1); CL (1); LI (2); IL (6); GU (1); IN (6); SL (5); BU (1); RU (3); ZA (6); BR (7); CR (1); US (83); AU (3); ES (1); ME (3); RO (3); NZ (2); SE (3); AR (6)