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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680745
• Other study ID #: D1690C00005
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2008
• Last updated: August 9, 2013
• Start date: April 2008
• Est. completion date: May 2010

Study information

• Verified date: August 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyIndia: Central Drugs Standard Control OrganizationIndia: Ministry of HealthKorea: Food and Drug AdministrationPhilippines: Bureau of Food and DrugsPoland: Ministry of HealthThailand: Food and Drug AdministrationUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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:
• dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
• Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
• metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
• pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
• Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Locations

Country	Name	City	State
Czech Republic	Research Site	Blansko
Czech Republic	Research Site	Breclav
Czech Republic	Research Site	Bruntal
Czech Republic	Research Site	Hodonin
Czech Republic	Research Site	Ostrava - Belsky Les
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha 1
Czech Republic	Research Site	Pribram Viii
Czech Republic	Research Site	Rakovnik
Czech Republic	Research Site	Semily
Hungary	Research Site	Balatonfured
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Budapest
Hungary	Research Site	Csongrad
Hungary	Research Site	Eger
Hungary	Research Site	Gyongyos
Hungary	Research Site	Kecskemet
Hungary	Research Site	Mako
Hungary	Research Site	Miskolc
Hungary	Research Site	Mosonmagyarovar
Hungary	Research Site	Siofok
Hungary	Research Site	Szentes
Hungary	Research Site	TAT
Hungary	Research Site	Zalaegerszeg
Korea, Republic of	Research Site	Bucheon
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeonju	Chonbuk
Korea, Republic of	Research Site	Seongnam
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon	Kyunggi-do
Korea, Republic of	Research Site	Uljeongbu
Korea, Republic of	Research Site	Wonju	Kangwon-do
Philippines	Research Site	Cebu City
Philippines	Research Site	Manila
Philippines	Research Site	Marikina City
Philippines	Research Site	Pasig City
Poland	Research Site	Bielsko - Biala
Poland	Research Site	Bydgoszcz
Poland	Research Site	Chojnice
Poland	Research Site	Chrzanow
Poland	Research Site	Ciechocinek
Poland	Research Site	Czechowice-Dziedzice
Poland	Research Site	Elblag
Poland	Research Site	Gdansk
Poland	Research Site	Gniewkowo
Poland	Research Site	Grudziadz
Poland	Research Site	Ilawa
Poland	Research Site	Krakow
Poland	Research Site	Mragowo
Poland	Research Site	Plock
Poland	Research Site	Poznan
Poland	Research Site	Ruda Slaska
Poland	Research Site	Sopot
Poland	Research Site	Torun
Poland	Research Site	Wroclaw
Poland	Research Site	Zabrze
Poland	Research Site	Zielona Gora
Poland	Research Site	Zory
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Ukraine	Research Site	Dnipropetrov'sk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kiev
Ukraine	Research Site	Vinnytsia
Ukraine	Research Site	Zaporozhye

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Korea, Republic of,  Philippines,  Poland,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Change in HbA1c Levels	To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Body Weight	To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise	To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.	Baseline to Week 24	No
Secondary	Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%	To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.	At Week 24	No
Secondary	Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)=27 kg/m2	To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI =27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Fasting Plasma Glucose (FPG)	To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.	Baseline to Week 24	No