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

Type 2 Diabetes Clinical Trial

Official title:

18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666458
• Other study ID #: D1680C00002
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2008
• Last updated: March 5, 2010
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and WelfareNorway: Norwegian Institute of Public HealthDenmark: National Board of HealthItaly: National Institute of HealthFrance: Direction Générale de la SantéSouth Africa: Department of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: Ministry of HealthMexico: Ministry of HealthBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 822
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• saxagliptin
tablet, per oral, once daily
• sitagliptin
capsule, per oral, once daily

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Capital Federal
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Lanus	Buenos Aires
Argentina	Research Site	Mar Del Plata	Buenos Aires
Argentina	Research Site	Rosario
Argentina	Research Site	Santa Fe
Belgium	Research Site	Aalst
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brugge
Belgium	Research Site	Genk
Belgium	Research Site	Gozee
Belgium	Research Site	Hasselt
Belgium	Research Site	Liege
Belgium	Research Site	Saint-medard
Belgium	Research Site	Sint-gillis-waas
Belgium	Research Site	Tessenderlo
Belgium	Research Site	Thuillies
Denmark	Research Site	Aalborg
Denmark	Research Site	Arhus
Denmark	Research Site	Christiansfeld
Denmark	Research Site	Farso
Denmark	Research Site	Gentofte
Denmark	Research Site	Hobro
Denmark	Research Site	Kolding
Denmark	Research Site	Rodovre
Denmark	Research Site	Viborg
France	Research Site	Angers
France	Research Site	Chateau Gontier
France	Research Site	Corbeil Essonnes
France	Research Site	La Seyne Sur Mer
France	Research Site	Laval
France	Research Site	Le Lavandou
France	Research Site	Montrevault
France	Research Site	Saint Cyr
France	Research Site	Tierce
France	Research Site	Toulon
France	Research Site	Witry Les Reims
Italy	Research Site	Bergamo	BG
Italy	Research Site	Chiavari	GE
Italy	Research Site	Foggia	FG
Italy	Research Site	Genova	GE
Italy	Research Site	Mercato San Severino	SA
Italy	Research Site	Olbia	OT
Italy	Research Site	Padova	PD
Italy	Research Site	Pordenone	PN
Italy	Research Site	Rozzano	MI
Italy	Research Site	Siena	SI
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Mexico	D.f.
Mexico	Research Site	Monterrey
Norway	Research Site	Alesund
Norway	Research Site	Elverum
Norway	Research Site	Halden
Norway	Research Site	Hamar
Norway	Research Site	Lierskogen
Norway	Research Site	Lillehammer
Norway	Research Site	Oslo
Norway	Research Site	Sandvika
Norway	Research Site	Strommen
Norway	Research Site	Svelvik
South Africa	Research Site	Benoni	Gauteng
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Cape Town	Western Cape
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Johannesburg	Gauteng
South Africa	Research Site	Kwa Zulu Natal
South Africa	Research Site	Pretoria
Sweden	Research Site	Boras
Sweden	Research Site	Degeberga
Sweden	Research Site	Finspang
Sweden	Research Site	Goteborg
Sweden	Research Site	Jonkoping
Sweden	Research Site	Odeshog
Sweden	Research Site	Orebro
Sweden	Research Site	Pitea
Sweden	Research Site	Rattvik
Sweden	Research Site	Skanor
Sweden	Research Site	Timra
Sweden	Research Site	Trollhattan
Sweden	Research Site	Uddevalla
Sweden	Research Site	Umea

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

Argentina,  Belgium,  Denmark,  France,  Italy,  Mexico,  Norway,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18	Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)	Week 18 (Last Observation Carried Forward)	No
Secondary	Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)	Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.	Baseline, Week 18 (Last Observation Carried Forward)	No
Secondary	Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)	Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.	Baseline, Week 18 (Last Observation Carried Forward)	No