Clinical trial NCT00680745: Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin
efficacy
safety
sulphonylurea
Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-05-20
Enrollment: 597
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 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.


Eligibility 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

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Adjusted Mean Change in Body Weight
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise
timeFrame: Baseline to Week 24
measure: Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
timeFrame: At Week 24
measure: Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Blansko
country: Czech Republic
facility: Research Site
city: Breclav
country: Czech Republic
facility: Research Site
city: Bruntal
country: Czech Republic
facility: Research Site
city: Hodonin
country: Czech Republic
facility: Research Site
city: Ostrava - Belsky Les
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Praha 1
country: Czech Republic
facility: Research Site
city: Pribram Viii
country: Czech Republic
facility: Research Site
city: Rakovnik
country: Czech Republic
facility: Research Site
city: Semily
country: Czech Republic
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Csongrad
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyongyos
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Mako
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Siofok
country: Hungary
facility: Research Site
city: Szentes
country: Hungary
facility: Research Site
city: TAT
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Jeonju
country: Korea, Republic of
facility: Research Site
state: Chonbuk
city: Wonju
country: Korea, Republic of
facility: Research Site
state: Kangwon-do
city: Suwon
country: Korea, Republic of
facility: Research Site
state: Kyunggi-do
city: Bucheon
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seongnam
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Uljeongbu
country: Korea, Republic of
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Marikina City
country: Philippines
facility: Research Site
city: Pasig City
country: Philippines
facility: Research Site
city: Bielsko - Biala
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chojnice
country: Poland
facility: Research Site
city: Chrzanow
country: Poland
facility: Research Site
city: Ciechocinek
country: Poland
facility: Research Site
city: Czechowice-Dziedzice
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gniewkowo
country: Poland
facility: Research Site
city: Grudziadz
country: Poland
facility: Research Site
city: Ilawa
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Mragowo
country: Poland
facility: Research Site
city: Plock
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Zielona Gora
country: Poland
facility: Research Site
city: Zory
country: Poland
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Dnipropetrov'sk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporozhye
country: Ukraine
facility: Research Site
Study officials:
affiliation: Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland
name: Krzysztof Strojek, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
citation: Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German.
citation: Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x.