Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

Condition(s) targeted: Type 2 Diabetes

Intervention: dapagliflozin (Drug); glipizide (Drug); metformin hydrochloride (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michael A. Nauck, Prof. Dr. med., Principal Investigator, Affiliation: Diabeteszentrum Bad Lauterberg, Germany

Overall contact:
AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin

To show that dapagliflozin plus metformin treatment leads to fewer patients with hypoglycaemic events compared to glipizide plus metformin

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 Exclusion Criteria:

- Type 1 Diabetes

- Insulin therapy within one year of enrolment

- Renal (kidney) failure or dysfunction

AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com

Research Site, BUENOS AIRES, Argentina; Not yet recruiting

Research Site, CAPITAL FEDERAL, Argentina; Recruiting

Research Site, CIUDAD AUTONOMA DE BS. AS., Argentina; Not yet recruiting

Research Site, CIUDAD DE BUENOS AIRES, Argentina; Recruiting

Research Site, CORDOBA, Argentina; Not yet recruiting

Research Site, CORRIENTES, Argentina; Recruiting

Research Site, SANTA FE, Argentina; Recruiting

Research Site, NANTES, France; Recruiting

Research Site, BAD LAUTERBERG, Germany; Not yet recruiting

Research Site, BERLIN, Germany; Recruiting

Research Site, DRESDEN, Germany; Not yet recruiting

Research Site, ESSEN, Germany; Not yet recruiting

Research Site, FRANKFURT, Germany; Recruiting

Research Site, HAMBURG, Germany; Recruiting

Research Site, HEILBRONN, Germany; Not yet recruiting

Research Site, LUDWIGSHAFEN, Germany; Not yet recruiting

Research Site, MAINZ, Germany; Not yet recruiting

Research Site, MUNCHEN, Germany; Not yet recruiting

Research Site, RATZEBURG, Germany; Not yet recruiting

Research Site, STUTTGART, Germany; Not yet recruiting

Research Site, WANGEN, Germany; Not yet recruiting

Research Site, FIRENZE, Italy; Not yet recruiting

Research Site, ROMA, Italy; Recruiting

Research Site, VERACRUZ, Mexico; Not yet recruiting

Research Site, DEN HAAG, Netherlands; Recruiting

Research Site, DEURNE, Netherlands; Recruiting

Research Site, GORINCHEM, Netherlands; Recruiting

Research Site, GRONINGEN, Netherlands; Not yet recruiting

Research Site, LICHTENVOORDE (GLD), Netherlands; Not yet recruiting

Research Site, LOSSER, Netherlands; Recruiting

Research Site, POORTVLIET, Netherlands; Recruiting

Research Site, ROTTERDAM, Netherlands; Recruiting

Research Site, WILDERVANK, Netherlands; Recruiting

Research Site, ZUTPHEN, Netherlands; Recruiting

Research Site, JOHANNESBURG, South Africa; Recruiting

Research Site, PRETORIA, South Africa; Not yet recruiting

Research Site, UMKOMAAS, South Africa; Recruiting

Research Site, ANGELHOLM, Sweden; Not yet recruiting

Research Site, GOTEBORG, Sweden; Recruiting

Research Site, JARFALLA, Sweden; Recruiting

Research Site, LUND, Sweden; Recruiting

Research Site, MALMO, Sweden; Not yet recruiting

Research Site, SKENE, Sweden; Recruiting

Research Site, SODERTALJE, Sweden; Recruiting

Research Site, STOCKHOLM, Sweden; Recruiting

Research Site, UMEA, Sweden; Recruiting

Research Site, BATH, United Kingdom; Recruiting

Research Site, BOLTON, United Kingdom; Recruiting

Research Site, BURY ST EDMONDS, United Kingdom; Recruiting

Research Site, COVENTRY, United Kingdom; Recruiting

Research Site, EDINBURGH, United Kingdom; Recruiting

Research Site, CABA, BA, Argentina; Recruiting

Research Site, BARI, BA, Italy; Not yet recruiting

Research Site, READING, BERKS, United Kingdom; Recruiting

Research Site, AYLESBURY, BUCKS, United Kingdom; Recruiting

Research Site, LA PLATA, Buenos Aires, Argentina; Recruiting

Research Site, CORNELLA DE LLOBREGAT (BCN), CATALUNA, Spain; Recruiting

Research Site, BARCELONA, CATALU�a, Spain; Not yet recruiting

Research Site, FORTALEZA, CE, Brazil; Not yet recruiting

Research Site, MADRID, Comunidad De Madrid, Spain; Recruiting

Research Site, ALICANTE, Comunidad Valenciana, Spain; Recruiting

Research Site, ALZIRA (VALENCIA), Comunidad Valenciana, Spain; Recruiting

Research Site, MEXICO, D.F., Mexico; Not yet recruiting

Research Site, WITBANK, GAUTENG, South Africa; Not yet recruiting

Research Site, GOIANIA, GO, Brazil; Not yet recruiting

Research Site, ACAPULCO, GUERRERO, Mexico; Not yet recruiting

Research Site, GUADALAJARA, JALISCO, Mexico; Not yet recruiting

Research Site, DURBAN, Kwazulu Natal, South Africa; Recruiting

Research Site, MILANO, MI, Italy; Not yet recruiting

Research Site, COOKSTOWN, N. IRELAND, United Kingdom; Recruiting

Research Site, BELEM, PA, Brazil; Not yet recruiting

Research Site, PADOVA, PD, Italy; Not yet recruiting

Research Site, RECIFE, PE, Brazil; Not yet recruiting

Research Site, PERUGIA, PG, Italy; Not yet recruiting

Research Site, PISA, PI, Italy; Recruiting

Research Site, CURITIBA, PR, Brazil; Not yet recruiting

Research Site, PORTO ALEGRE, RS, Brazil; Not yet recruiting

Research Site, ROSARIO, SANTA FE, Argentina; Not yet recruiting

Research Site, ECCLESFIELD, SHEFFIELD, United Kingdom; Recruiting

Research Site, SAO PAULO, SP, Brazil; Not yet recruiting

Research Site, ADDLESTONE, SURREY, United Kingdom; Recruiting

Research Site, PAROW, W CAPE, South Africa; Not yet recruiting

Research Site, TROWBRIDGE, WILTSHIRE, United Kingdom; Recruiting

Research Site, CAPE TOWN, Western Cape, South Africa; Not yet recruiting

Starting date: March 2008
Ending date: February 2011
Last updated: July 31, 2008