Clinical trial NCT00660907: Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
Official title: A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin
efficacy
safety
metformin
Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-04-17
Enrollment: 1217
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 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.


Eligibility 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 \</=10%

Exclusion Criteria:

* Type 1 Diabetes
* Insulin therapy within one year of enrolment
* Renal (kidney) failure or dysfunction

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Adjusted Mean Change in Body Weight
timeFrame: Baseline to Week 52
measure: Proportion of Participants With at Least One Episode of Hypoglycemia
timeFrame: Baseline to Week 52
measure: Proportion of Participants With Body Weight Reduction of at Least 5%
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Corrientes
country: Argentina
facility: Research Site
city: Córdoba
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: L'aigle
country: France
facility: Research Site
city: Murs Erigne
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Vannes
country: France
facility: Research Site
city: Bad Lauterberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heilbronn
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Schmiedeberg
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Acapulco
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: México
country: Mexico
facility: Research Site
city: Veracruz
country: Mexico
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Deurne
country: Netherlands
facility: Research Site
city: Gorinchem
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Lichtenvoorde (gld)
country: Netherlands
facility: Research Site
city: Losser
country: Netherlands
facility: Research Site
city: Poortvliet
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Wildervank
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Parow
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Umkomaas
country: South Africa
facility: Research Site
city: Witbank
country: South Africa
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Alzira (Valencia)
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cornellá de Llobregat (BCN)
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Järfälla
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Skene
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Södertälje
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Addlestone
country: United Kingdom
facility: Research Site
city: Aylesbury
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Bury St Edmonds
country: United Kingdom
facility: Research Site
city: Cookstown
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Ecclesfield
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Mortimer Reading
country: United Kingdom
facility: Research Site
city: Trowbridge
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Diabeteszentrum Bad Lauterberg, Germany
name: Michael A. Nauck, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nauck MA, Del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep;34(9):2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4.
citation: Nauck M, del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. [Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S6-15. doi: 10.1055/s-0032-1305283. Epub 2013 Mar 25. German.