18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

NCT ID: NCT00666458

Last Updated: 2010-04-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

822 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

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Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

saxagliptin add-on to metformin

Group Type EXPERIMENTAL

saxagliptin

Intervention Type DRUG

tablet, per oral, once daily

2

sitagliptin add-on to metformin

Group Type ACTIVE_COMPARATOR

sitagliptin

Intervention Type DRUG

capsule, per oral, once daily

Interventions

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saxagliptin

tablet, per oral, once daily

Intervention Type DRUG

sitagliptin

capsule, per oral, once daily

Intervention Type DRUG

Other Intervention Names

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Onglyza Januvia

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes
* Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks

Exclusion Criteria

* Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
* Insulin therapy within one year
* Previous treatment with DPP-4 inhibitor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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André Scheen, Professor

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Unit, Liege, Belgium

Peter Öhman, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca, Wilmington, USA

Deborah Price, MSc

Role: STUDY_CHAIR

AstraZeneca, Wilmington, USA

Locations

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Research Site

Buenos Aires, Buenos Aires, Argentina

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Lanús, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Caba, , Argentina

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Capital Federal, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Córdoba, , Argentina

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Rosario, , Argentina

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Aalst, Belgium, Belgium

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Bonheiden, Belgium, Belgium

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Genk, Belgium, Belgium

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Gozée, Belgium, Belgium

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Hasselt, Belgium, Belgium

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Liège, Belgium, Belgium

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Saint-Médard, Belgium, Belgium

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Sint-Gillis-Waas, Belgium, Belgium

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Tessenderlo, Belgium, Belgium

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Thuillies, Belgium, Belgium

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Bruges, , Belgium

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Aalborg, , Denmark

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Aarhus, , Denmark

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Christiansfeld, , Denmark

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Farsø, , Denmark

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Gentofte Municipality, , Denmark

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Hobro, , Denmark

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Kolding, , Denmark

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Rødovre Municipality, , Denmark

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Viborg, , Denmark

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Angers, , France

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Château-Gontier, , France

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Corbeil-Essonnes, , France

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La Seyne-sur-Mer, , France

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Laval, , France

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Le Lavandou, , France

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Montrevault, , France

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Saint-Cyr, , France

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Tiercé, , France

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Toulon, , France

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Witry-lès-Reims, , France

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Bergamo, BG, Italy

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Foggia, FG, Italy

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Chiavari, GE, Italy

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Genova, GE, Italy

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Rozzano, MI, Italy

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Olbia, OT, Italy

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Padua, PD, Italy

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Pordenone, PN, Italy

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Mercato San Severino, SA, Italy

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Siena, SI, Italy

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México, D.f., Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, , Mexico

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Ålesund, , Norway

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Elverum, , Norway

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Halden, , Norway

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Hamar, , Norway

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Lierskogen, , Norway

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Lillehammer, , Norway

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Oslo, , Norway

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Sandvika, , Norway

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Strømmen, , Norway

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Svelvik, , Norway

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Benoni, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Cape Town, South Africa, South Africa

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Durban, South Africa, South Africa

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Cape Town, Western Cape, South Africa

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Bloemfontein, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Kwa Zulu Natal, , South Africa

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Pretoria, , South Africa

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Borås, , Sweden

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Degeberga, , Sweden

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Finspång, , Sweden

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Gothenburg, , Sweden

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Jönköping, , Sweden

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Ödeshög, , Sweden

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Örebro, , Sweden

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Piteå, , Sweden

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Rättvik, , Sweden

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Skanör, , Sweden

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Timrå, , Sweden

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Trollhättan, , Sweden

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Uddevalla, , Sweden

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Umeå, , Sweden

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Countries

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Argentina Belgium Denmark France Italy Mexico Norway South Africa Sweden

Other Identifiers

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EudraCT number 2007-006095-11

Identifier Type: -

Identifier Source: secondary_id

D1680C00002

Identifier Type: -

Identifier Source: org_study_id

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