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

NCT00666458 | Completed Phase 3 Results DMC

• 2 other identifiers: D1680C00002EudraCT number 2007-006095-11
• Study Type: interventional
• Target: 822
• Locations: 9 countries
• Sites: 87

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; metformin

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c) Change From Baseline to Week 18

  Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.

  Baseline, Week 18

Secondary Outcomes (3)

• Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18

  Week 18 (Last Observation Carried Forward)

• Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)

  Baseline, Week 18 (Last Observation Carried Forward)

• Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)

  Baseline, Week 18 (Last Observation Carried Forward)

Study Arms (2)

1

EXPERIMENTAL

saxagliptin add-on to metformin

Drug: saxagliptin

2

ACTIVE COMPARATOR

sitagliptin add-on to metformin

Drug: sitagliptin

Interventions

saxagliptin DRUG

tablet, per oral, once daily

Also known as: Onglyza

1

sitagliptin DRUG

capsule, per oral, once daily

Also known as: Januvia

2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (87)

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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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• André Scheen, Professor

  Clinical Pharmacology Unit, Liege, Belgium

  PRINCIPAL INVESTIGATOR

• Peter Öhman, MD, PhD

  AstraZeneca, Wilmington, USA

  STUDY DIRECTOR

• Deborah Price, MSc

  AstraZeneca, Wilmington, USA

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 15, 2010
• Results First Posted: April 15, 2010

Record last verified: 2010-03

Locations

NO (10); FR (11); ME (3); DK (9); AR (9); ZA (10); SE (14); BE (11); IT (10)