Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2010-11-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Dapagliflozin 2.5 mg twice-daily plus open-label metformin
dapagliflozin
2.5 mg tablet, taken orally, twice daily
metformin
\>/= 1500 mg total daily dose, tablets taken orally, twice daily
2
Dapagliflozin 5.0 mg twice-daily plus open-label metformin
dapagliflozin
5 mg tablet taken orally, twice daily
metformin
\>/= 1500 mg total daily dose, tablets taken orally, twice daily
3
Dapagliflozin 10 mg once-daily plus open-label metformin
dapagliflozin
10 mg tablet taken orally, once daily
metformin
\>/= 1500 mg total daily dose, tablets taken orally, twice daily
4
Placebo plus open-label metformin
metformin
\>/= 1500 mg total daily dose, tablets taken orally, twice daily
placebo
placebo
Interventions
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dapagliflozin
2.5 mg tablet, taken orally, twice daily
dapagliflozin
5 mg tablet taken orally, twice daily
dapagliflozin
10 mg tablet taken orally, once daily
metformin
\>/= 1500 mg total daily dose, tablets taken orally, twice daily
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of T2DM
* Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy \>/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
* HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.
Exclusion Criteria
* History of diabetic ketoacidosis
* Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
* FPG \>270 mg/dL (\>15.0 mmol/L)
* BMI \>45 kg/m2
18 Years
77 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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Shamik Parikh
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Aßlar, , Germany
Research Site
Berlin, , Germany
Research Site
Biberach A.d. Riss, , Germany
Research Site
Bosenheim, , Germany
Research Site
Dippoldiswalde, , Germany
Research Site
Falkensee, , Germany
Research Site
Meissen, , Germany
Research Site
München, , Germany
Research Site
Neuwied, , Germany
Research Site
Pirna, , Germany
Research Site
Wahlstedt, , Germany
Research Site
Balatonfüred, , Hungary
Research Site
Budapest, , Hungary
Research Site
Csongrád, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Gyöngyös, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Makó, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Tát, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Brasov, Brașov County, Romania
Research Site
Bucharest, , Romania
Research Site
Iași, , Romania
Research Site
Sibiu, , Romania
Research Site
Suceava, , Romania
Research Site
Banská Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Dolný Kubín, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Lučenec, , Slovakia
Research Site
Námestovo, , Slovakia
Research Site
Piešťany, , Slovakia
Research Site
Prievidza, , Slovakia
Research Site
Rimavská Sobota, , Slovakia
Research Site
Ružomberok, , Slovakia
Research Site
Žilina, , Slovakia
Research Site
Verulam, KwaZulu-Natal, South Africa
Research Site
Cape Town, South Africa, South Africa
Research Site
Durban, South Africa, South Africa
Research Site
eMkhomazi, South Africa, South Africa
Research Site
Johannesburg, South Africa, South Africa
Research Site
Durban, , South Africa
Research Site
Chur, Kanton Graubünden, Switzerland
Research Site
Basel, , Switzerland
Research Site
Bern, , Switzerland
Research Site
Geneva, , Switzerland
Research Site
Kreuzlingen, , Switzerland
Research Site
Lugano, , Switzerland
Research Site
Rorschach, , Switzerland
Research Site
Vynnitsa, Ukraine, Ukraine
Research Site
Zaporizhzhya, Ukraine, Ukraine
Research Site
Dnipropetrov'sk, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Vinnytsia, , Ukraine
Countries
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References
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Schumm-Draeger PM, Burgess L, Koranyi L, Hruba V, Hamer-Maansson JE, de Bruin TW. Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial. Diabetes Obes Metab. 2015 Jan;17(1):42-51. doi: 10.1111/dom.12387. Epub 2014 Oct 16.
Related Links
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CSR-D1691C00003.pdf
D1691C00003\_Clinical\_Study\_Protocol\_Redacted
Other Identifiers
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D1691C00003
Identifier Type: -
Identifier Source: org_study_id
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