Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
NCT ID: NCT00855166
Last Updated: 2013-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
182 participants
INTERVENTIONAL
2009-02-28
2011-12-31
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
DOUBLE
Study Groups
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A
Dapagliflozin 10 mg plus Metformin
Dapagliflozin
Tablet oral 10 mg total daily dose once daily 102 weeks
Metformin
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Sitagliptin
Tablet oral 100 mg total daily dose once daily rescue medication
B
Placebo plus Metformin
Metformin
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Sitagliptin
Tablet oral 100 mg total daily dose once daily rescue medication
Placebo
Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks
Interventions
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Dapagliflozin
Tablet oral 10 mg total daily dose once daily 102 weeks
Metformin
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Sitagliptin
Tablet oral 100 mg total daily dose once daily rescue medication
Placebo
Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks
Eligibility Criteria
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Inclusion Criteria
* Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
* Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
* ≥30 years for males
* ≥55 years for females
Exclusion Criteria
* Body weight change \>5% within 3 months prior to enrolment
* Renal and liver impairment
30 Years
75 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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Jan Bolinder, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden
Locations
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Research Site
Blagoevgrad, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Beroun, , Czechia
Research Site
Brno, , Czechia
Research Site
Prague, , Czechia
Research Site
Semily, , Czechia
Research Site
Slaný, , Czechia
Research Site
Balatonfüred, , Hungary
Research Site
Budapest, , Hungary
Research Site
Csongrád, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Tát, , Hungary
Research Site
Elblag, , Poland
Research Site
Krakow, , Poland
Research Site
Torun, , Poland
Research Site
Gothenburg, , Sweden
Research Site
Jarfalla, , Sweden
Research Site
Lund, , Sweden
Research Site
Malmo, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Uppsala, , Sweden
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.
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.
Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.
Ljunggren O, Bolinder J, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab. 2012 Nov;14(11):990-9. doi: 10.1111/j.1463-1326.2012.01630.x. Epub 2012 Jun 29.
Other Identifiers
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D1690C00012
Identifier Type: -
Identifier Source: org_study_id