Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

Condition(s) targeted: Type 2 Diabetes

Intervention: dapagliflozin (Drug); Glimepiride (Drug); metformin hydrochloride (Drug); pioglitazone hydrochloride (Drug); Rosiglitazone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Krzysztof Strojek, Prof. Dr., Principal Investigator, Affiliation: Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland

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 in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Official title: A 24-Week,Int.,Rand.,Double-Blind,Parallel-Group,Multi-Centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone

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

Primary outcome: To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycaemic control in subjects with type 2 diabetes, as determined by the change in A1C levels from baseline to Week 24

Secondary outcome:

To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.

To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose level as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.

To show that dapagliflozin plus glimepiride results in a larger proportion of subjects achieving a therapeutic glycaemic response, defined as A1C < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.

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

Criteria:

Inclusion Criteria:

- Type 2 Diabetes

- Treatment with a stable sulphonylurea monotherapy dose that is at least half the

maximal recommended dose for a minimum of 8 weeks prior to study

- Inadequate glycaemic control, defined as A1C ≥ 7. 0 % and ≤ 10%

Exclusion Criteria:

- Type 1 Diabetes

- Hepatic (liver) impairment

- Renal (kidney) failure or dysfunction

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

Research Site, BLANSKO, Czech Republic; Recruiting

Research Site, BRECLAV, Czech Republic; Recruiting

Research Site, BRUNTAL, Czech Republic; Recruiting

Research Site, HODONIN, Czech Republic; Recruiting

Research Site, OSTRAVA - BELSKY LES, Czech Republic; Recruiting

Research Site, PLZEN, Czech Republic; Recruiting

Research Site, PRAHA 1, Czech Republic; Recruiting

Research Site, PRIBRAM VIII, Czech Republic; Recruiting

Research Site, RAKOVNIK, Czech Republic; Recruiting

Research Site, SEMILY, Czech Republic; Recruiting

Research Site, TABOR, Czech Republic; Not yet recruiting

Research Site, USTI NAD LABEM, Czech Republic; Not yet recruiting

Research Site, BALATONFURED, Hungary; Recruiting

Research Site, BEKESCSABA, Hungary; Recruiting

Research Site, BUDAPEST, Hungary; Recruiting

Research Site, CSONGRAD, Hungary; Recruiting

Research Site, EGER, Hungary; Recruiting

Research Site, GYONGYOS, Hungary; Recruiting

Research Site, KECSKEMET, Hungary; Recruiting

Research Site, MAKO, Hungary; Recruiting

Research Site, MISKOLC, Hungary; Recruiting

Research Site, MOSONMAGYAROVAR, Hungary; Recruiting

Research Site, SIOFOK, Hungary; Recruiting

Research Site, SZENTES, Hungary; Recruiting

Research Site, TAT, Hungary; Recruiting

Research Site, ZALAEGERSZEG, Hungary; Recruiting

Research Site, KARNAL, India; Not yet recruiting

Research Site, BUCHEON, Korea, Republic of; Recruiting

Research Site, INCHEON, Korea, Republic of; Recruiting

Research Site, SEONGNAM, Korea, Republic of; Recruiting

Research Site, SEOUL, Korea, Republic of; Recruiting

Research Site, UIJEONGBU-SI, Korea, Republic of; Not yet recruiting

Research Site, PASIG CITY, Philippines; Recruiting

Research Site, CEBU CITY, Philippines; Recruiting

Research Site, MARIKINA CITY, Philippines; Recruiting

Research Site, BIELSKO - BIALA, Poland; Recruiting

Research Site, BYDGOSZCZ, Poland; Recruiting

Research Site, CHOJNICE, Poland; Recruiting

Research Site, CHRZANOW, Poland; Recruiting

Research Site, CIECHOCINEK, Poland; Recruiting

Research Site, CZECHOWICE-DZIEDZICE, Poland; Recruiting

Research Site, ELBLAG, Poland; Recruiting

Research Site, GDANSK, Poland; Recruiting

Research Site, GNIEWKOWO, Poland; Recruiting

Research Site, GRUDZIADZ, Poland; Recruiting

Research Site, ILAWA, Poland; Recruiting

Research Site, KRAKOW, Poland; Recruiting

Research Site, MRAGOWO, Poland; Recruiting

Research Site, PLOCK, Poland; Recruiting

Research Site, POZNAN, Poland; Recruiting

Research Site, RUDA SLASKA, Poland; Recruiting

Research Site, SOPOT, Poland; Recruiting

Research Site, TORUN, Poland; Recruiting

Research Site, WARSZAWA, Poland; Not yet recruiting

Research Site, WROCLAW, Poland; Recruiting

Research Site, ZABRZE, Poland; Recruiting

Research Site, ZIELONA GORA, Poland; Recruiting

Research Site, ZORY, Poland; Recruiting

Research Site, BANGKOK, Thailand; Recruiting

Research Site, CHIANG MAI, Thailand; Recruiting

Research Site, DNIPROPETROV'SK, Ukraine; Recruiting

Research Site, DONETSK, Ukraine; Recruiting

Research Site, KHARKIV, Ukraine; Not yet recruiting

Research Site, KIEV, Ukraine; Recruiting

Research Site, VINNYTSIA, Ukraine; Not yet recruiting

Research Site, ZAPOROZHYE, Ukraine; Not yet recruiting

Research Site, JEONJU, CHONBUK, Korea, Republic of; Recruiting

Research Site, WONJU, KANGWON-DO, Korea, Republic of; Recruiting

Research Site, SUWON, KYUNGGI-DO, Korea, Republic of; Recruiting

Research Site, MUMBAI, MAHARASHTRA, India; Not yet recruiting

Research Site, PUNE, MAHARASHTRA, India; Not yet recruiting

Research Site, MUMBAI, MASHATRA, India; Not yet recruiting

Research Site, INDORE, Madhya Pradesh, India; Not yet recruiting

Starting date: April 2008
Ending date: May 2010
Last updated: February 3, 2009