Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients - Full Text View

Sponsor:	AstraZeneca
Collaborator:	Bristol-Myers Squibb
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00660907

Purpose

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: dapagliflozin Drug: glipizide Drug: metformin hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Adult Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glipizide BMS 512148 Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To examine whether the absolute change from baseline in HbA1c level with dapagliflozin plus metformin is non-inferior to glipizide plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on metformin therapy alone [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: Yes ]
To show that dapagliflozin plus metformin treatment leads to fewer patients with hypoglycaemic events compared to glipizide plus metformin [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	746
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dapagliflozin plus metformin	Drug: dapagliflozin tablet oral 2.5, 5, or 10 mg total daily dose once daily 104 weeks Drug: metformin hydrochloride tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 114 weeks
2: Active Comparator glipizide plus metformin	Drug: glipizide capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 104 weeks Drug: metformin hydrochloride tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 114 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes
Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
HbA1c >6.5% and </=10%

Exclusion Criteria:

Type 1 Diabetes
Insulin therapy within one year of enrolment
Renal (kidney) failure or dysfunction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660907

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Locations

Argentina
Research Site
BUENOS AIRES, Argentina
Research Site
CAPITAL FEDERAL, Argentina
Research Site
CIUDAD AUTONOMA DE BS. AS., Argentina
Research Site
CIUDAD DE BUENOS AIRES, Argentina
Research Site
CORDOBA, Argentina
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CORRIENTES, Argentina
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SANTA FE, Argentina
Argentina, BA
Research Site
CABA, BA, Argentina
Argentina, Buenos Aires
Research Site
LA PLATA, Buenos Aires, Argentina
Argentina, SANTA FE
Research Site
ROSARIO, SANTA FE, Argentina
France
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NANTES, France
Research Site
L'Aigle, France
Research Site
Murs Erigne, France
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Paris, France
Research Site
Tours, France
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Vannes, France
Germany
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FRANKFURT, Germany
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BERLIN, Germany
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DRESDEN, Germany
Research Site
ESSEN, Germany
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BAD LAUTERBERG, Germany
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HAMBURG, Germany
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HEILBRONN, Germany
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LUDWIGSHAFEN, Germany
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MAINZ, Germany
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MUNCHEN, Germany
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RATZEBURG, Germany
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STUTTGART, Germany
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WANGEN, Germany
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Pirna, Germany
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Schmiedeberg, Germany
Italy
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FIRENZE, Italy
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ROMA, Italy
Italy, BA
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BARI, BA, Italy
Italy, MI
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MILANO, MI, Italy
Italy, PD
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PADOVA, PD, Italy
Italy, PG
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PERUGIA, PG, Italy
Italy, PI
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PISA, PI, Italy
Mexico
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VERACRUZ, Mexico
Mexico, D.F.
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MEXICO, D.F., Mexico
Mexico, GUERRERO
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ACAPULCO, GUERRERO, Mexico
Mexico, JALISCO
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GUADALAJARA, JALISCO, Mexico
Netherlands
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DEN HAAG, Netherlands
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DEURNE, Netherlands
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GORINCHEM, Netherlands
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GRONINGEN, Netherlands
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LICHTENVOORDE (GLD), Netherlands
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LOSSER, Netherlands
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POORTVLIET, Netherlands
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ROTTERDAM, Netherlands
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WILDERVANK, Netherlands
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ZUTPHEN, Netherlands
South Africa
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JOHANNESBURG, South Africa
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PRETORIA, South Africa
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UMKOMAAS, South Africa
South Africa, GAUTENG
Research Site
WITBANK, GAUTENG, South Africa
South Africa, Kwazulu Natal
Research Site
DURBAN, Kwazulu Natal, South Africa
South Africa, W CAPE
Research Site
PAROW, W CAPE, South Africa
South Africa, Western Cape
Research Site
CAPE TOWN, Western Cape, South Africa
Spain, CATALU�a
Research Site
BARCELONA, CATALU�a, Spain
Spain, CATALUNA
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CORNELLA DE LLOBREGAT (BCN), CATALUNA, Spain
Spain, Comunidad De Madrid
Research Site
MADRID, Comunidad De Madrid, Spain
Spain, Comunidad Valenciana
Research Site
ALICANTE, Comunidad Valenciana, Spain
Research Site
ALZIRA (VALENCIA), Comunidad Valenciana, Spain
Sweden
Research Site
ANGELHOLM, Sweden
Research Site
GOTEBORG, Sweden
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JARFALLA, Sweden
Research Site
LUND, Sweden
Research Site
MALMO, Sweden
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SKENE, Sweden
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SODERTALJE, Sweden
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STOCKHOLM, Sweden
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UMEA, Sweden
United Kingdom
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BATH, United Kingdom
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BOLTON, United Kingdom
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BURY ST EDMONDS, United Kingdom
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COVENTRY, United Kingdom
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EDINBURGH, United Kingdom
United Kingdom, BERKS
Research Site
READING, BERKS, United Kingdom
United Kingdom, BUCKS
Research Site
AYLESBURY, BUCKS, United Kingdom
United Kingdom, N. IRELAND
Research Site
COOKSTOWN, N. IRELAND, United Kingdom
United Kingdom, SHEFFIELD
Research Site
ECCLESFIELD, SHEFFIELD, United Kingdom
United Kingdom, SURREY
Research Site
ADDLESTONE, SURREY, United Kingdom
United Kingdom, WILTSHIRE
Research Site
TROWBRIDGE, WILTSHIRE, United Kingdom

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Principal Investigator:

Michael A. Nauck, Prof. Dr. med.

Diabeteszentrum Bad Lauterberg, Germany

More Information

No publications provided

Responsible Party:	AstraZeneca ( Shamik Parikh, MDSr. Director, Medical Science )
Study ID Numbers:	D1690C00004
Study First Received:	April 15, 2008
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00660907 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Mexico: Federal Commission for Protection Against Health Risks; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Dapagliflozin
efficacy
safety
metformin
Type 2 diabetes

Additional relevant MeSH terms:

Hypoglycemic Agents
Glipizide
Metabolic Diseases
Physiological Effects of Drugs
Metformin

Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009