Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
NCT ID: NCT00673231
Last Updated: 2013-10-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1240 participants
INTERVENTIONAL
2008-04-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
2.5mg
Dapagliflozin
tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Dapagliflozin
tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
2
5mg
Dapagliflozin
Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
3
10mg
Dapagliflozin
Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Dapagliflozin
tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
4
Placebo
Placebo
Interventions
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Dapagliflozin
tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Dapagliflozin
Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Dapagliflozin
Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Placebo
Placebo
Dapagliflozin
tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
Dapagliflozin
tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
Eligibility Criteria
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Inclusion Criteria
* Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs
Exclusion Criteria
* Treatment with more than two additional oral antidiabetic drugs
* Moderate and severe renal (kidney) failure or dysfunction
18 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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John Wilding, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Sciences CentreUniversity Hospital AintreeLongmoor LaneLiverpool, UK
Locations
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Research Site
Fresno, California, United States
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Greenbrae, California, United States
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Roswell, Georgia, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Omaha, Nebraska, United States
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Philadelphia, Pennsylvania, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Salzburg, , Austria
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Vienna, , Austria
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Pleven, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Kelowna, British Columbia, Canada
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Langley, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Etobicoke, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Oakville, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Thornhill, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Longueuil, Quebec, Canada
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Mirabel, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Lahti, Finland, Finland
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Helsinki, , Finland
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Joensuu, , Finland
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Jyväskylä, , Finland
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Kuopio, , Finland
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Oulu, , Finland
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Seinäjoki, , Finland
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Turku, , Finland
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Bad Oeynhausen, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Magdeburg, , Germany
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Münster, , Germany
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Riesa, , Germany
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Wolmirstedt, , Germany
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Csongrád, , Hungary
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Esztergom, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Kecskemét, , Hungary
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Komárom, , Hungary
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Miskolc, , Hungary
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Székesfehérvár, , Hungary
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Veszprém, , Hungary
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Amersfoort, , Netherlands
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Den Helder, , Netherlands
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Leiden, , Netherlands
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Rotterdam, , Netherlands
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Brasov, Brașov County, Romania
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Tg Mures, Mureș County, Romania
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Bucharest, , Romania
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Saint Petersburg, , Russia
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Bratislava, , Slovakia
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Dolný Kubín, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Lučenec, , Slovakia
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Považská Bystrica, , Slovakia
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Prešov, , Slovakia
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Seville, Andalusia, Spain
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Sabadell (barcelona), Catalonia, Spain
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Madrid, Madrid, Spain
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Alicante, Valencia, Spain
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Reading, Berks, United Kingdom
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Aylesbury, Bucks, United Kingdom
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Ashford, , United Kingdom
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Birmingham, , United Kingdom
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Cardiff, , United Kingdom
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Liverpool, , United Kingdom
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Reading, , United Kingdom
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Swansea, , United Kingdom
Countries
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References
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Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Aberle J, Menzen M, Schmid SM, Terkamp C, Jaeckel E, Rohwedder K, Scheerer MF, Xu J, Tang W, Birkenfeld AL. Dapagliflozin effects on haematocrit, red blood cell count and reticulocytes in insulin-treated patients with type 2 diabetes. Sci Rep. 2020 Dec 28;10(1):22396. doi: 10.1038/s41598-020-78734-z.
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.
Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
van Haalen HG, Pompen M, Bergenheim K, McEwan P, Townsend R, Roudaut M. Cost effectiveness of adding dapagliflozin to insulin for the treatment of type 2 diabetes mellitus in the Netherlands. Clin Drug Investig. 2014 Feb;34(2):135-46. doi: 10.1007/s40261-013-0155-0.
Wilding JP, Woo V, Rohwedder K, Sugg J, Parikh S; Dapagliflozin 006 Study Group. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab. 2014 Feb;16(2):124-36. doi: 10.1111/dom.12187. Epub 2013 Aug 29.
Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Studiengruppe Dapagliflozin 006. [Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S27-38. doi: 10.1055/s-0032-1305284. Epub 2013 Mar 25. German.
Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Dapagliflozin 006 Study Group. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):405-15. doi: 10.7326/0003-4819-156-6-201203200-00003.
Other Identifiers
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D1690C00006
Identifier Type: -
Identifier Source: org_study_id