Clinical trial NCT01392677: Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
Official title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
High HbA1c Level
Inadequate Glycaemic Control
Keywords: dapagliflozin
diabetes
hyperglycaemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2011-07-12
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Men or women age ≥ 18 years old
* Stable dose combination of metformin and sulfonylurea
* HbA1c ≥7.7% and ≤11.0%

Exclusion Criteria:

* Type 1 diabetes mellitus or diabetes insipidus
* Recent cardiovascular events
* Kidney or urological disorders
* Hepatic disorders

Primary outcomes:
measure: Adjusted Mean Change From Baseline in HbA1c Levels
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in FPG
timeFrame: Baseline to week 24
measure: Adjusted Mean Change From Baseline in Total Body Weight
timeFrame: Baseline to week 24
measure: Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)
timeFrame: Baseline to week 24
measure: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure
timeFrame: Baseline to week 8
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Sydney Mines
country: Canada
facility: Research Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Smiths Falls
country: Canada
facility: Research Site
state: Ontario
city: Kensington
country: Canada
facility: Research Site
state: Prince Edward Island
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Beroun
country: Czech Republic
facility: Research Site
city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Jilove U Prahy
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Semily
country: Czech Republic
facility: Research Site
city: Vyskov
country: Czech Republic
facility: Research Site
city: Asslar
country: Germany
facility: Research Site
city: Aßlar
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Falkensee
country: Germany
facility: Research Site
city: Neuwied
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zgierz
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Sta Coloma de Gramanet (bcn)
country: Spain
facility: Research Site
state: Catalu?a
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: A Coruna
country: Spain
facility: Research Site
state: Galicia
city: A Coruña
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Sta Coloma de Gramenet (BCN)
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
name: Eva Johnsson, PhD, Medical Science Director
role: STUDY_DIRECTOR
affiliation: Diabetes-Zentrum Quakenbruck
name: Stephan Matthaei, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15.