Clinical trial NCT00673231: Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
Official title: A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes With Inadequate Glycaemic Control on Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin
efficacy
safety
add on to insulin
Oral AntiDiabetic
Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-05-07
Enrollment: 1240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* 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:

* Type 1 Diabetes
* Treatment with more than two additional oral antidiabetic drugs
* Moderate and severe 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 Calculated Mean Daily Insulin Dose
timeFrame: Baseline to Week 24
measure: Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 24
Other outcomes:
measure: Proportion of Participants With Lack of Glycemic Control
timeFrame: Baseline to Week 24
Locations:
city: Fresno
country: United States
facility: Research Site
state: California
city: Greenbrae
country: United States
facility: Research Site
state: California
city: Roswell
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Salzburg
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Langley
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Oakville
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: Thornhill
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Longueuil
country: Canada
facility: Research Site
state: Quebec
city: Mirabel
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Helsinki
country: Finland
facility: Research Site
city: Joensuu
country: Finland
facility: Research Site
city: Jyvaskyla
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Lahti
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Seinajoki
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Bad Oeynhausen
country: Germany
facility: Research Site
city: Dortmund
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: Magdeburg
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Riesa
country: Germany
facility: Research Site
city: Wolmirstedt
country: Germany
facility: Research Site
city: Csongrad
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Komarom
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
city: Amersfoort
country: Netherlands
facility: Research Site
city: Den Helder
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Tg Mures
country: Romania
facility: Research Site
state: Mures
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhnii Novgorod
country: Russian Federation
facility: Research Site
city: Saint- Petersburg
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St.-petersburg
country: Russian Federation
facility: Research Site
city: St.petersburg
country: Russian Federation
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Dolny Kubin
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Sabadell (barcelona)
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Reading
country: United Kingdom
facility: Research Site
state: Berks
city: Aylesbury
country: United Kingdom
facility: Research Site
state: Bucks
city: Ashford
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Clinical Sciences CentreUniversity Hospital AintreeLongmoor LaneLiverpool, UK
name: John Wilding, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.