Evaluation of Dapagliflozin Taken Twice-daily
Overview[ - collapse ][ - ]
Purpose | This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone. |
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Condition | Type 2 Diabetes |
Intervention | Drug: dapagliflozin Drug: dapagliflozin Drug: dapagliflozin Drug: metformin Drug: placebo |
Phase | Phase 3 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT01217892 |
First Received | October 7, 2010 |
Last Updated | October 31, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 7, 2010 |
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Last Updated Date | October 31, 2013 |
Start Date | November 2010 |
Estimated Primary Completion Date | August 2011 |
Current Primary Outcome Measures | Adjusted Mean Change in HbA1c Levels [Time Frame: Baseline to Week 16] [Designated as safety issue: No]To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Evaluation of Dapagliflozin Taken Twice-daily |
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Official Title | A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy |
Brief Summary | This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | Drug: dapagliflozin 2.5 mg tablet, taken orally, twice daily Drug: dapagliflozin 5 mg tablet taken orally, twice daily Drug: dapagliflozin 10 mg tablet taken orally, once daily Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily Drug: placebo placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 400 |
Estimated Completion Date | August 2011 |
Estimated Primary Completion Date | August 2011 |
Eligibility Criteria | Inclusion Criteria: - Provision of informed consent prior to any study specific procedures - 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: - Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus - 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Germany, Hungary, Romania, Slovakia, South Africa, Switzerland, Ukraine |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01217892 |
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Other Study ID Numbers | D1691C00003 |
Has Data Monitoring Committee | No |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Bristol-Myers Squibb |
Investigators | Study Director: Shamik Parikh AstraZeneca |
Verification Date | October 2013 |
Locations[ + expand ][ + ]
Research Site | Asslar, Germany |
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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 | Munchen, Germany |
Research Site | Neuwied, Germany |
Research Site | Pirna, Germany |
Research Site | Wahlstedt, Germany |
Research Site | Balatonfured, Hungary |
Research Site | Budapest, Hungary |
Research Site | Csongrad, Hungary |
Research Site | Debrecen, Hungary |
Research Site | Gyongyos, Hungary |
Research Site | Kecskemet, Hungary |
Research Site | Mako, Hungary |
Research Site | Nyiregyhaza, Hungary |
Research Site | TAT, Hungary |
Research Site | Zalaegerszeg, Hungary |
Research Site | Brasov, Romania |
Research Site | Bucuresti, Romania |
Research Site | Iasi, Romania |
Research Site | Sibiu, Romania |
Research Site | Suceava, Romania |
Research Site | Banska Bystrica, Slovakia |
Research Site | Bratislava, Slovakia |
Research Site | Dolny Kubin, Slovakia |
Research Site | Kosice, Slovakia |
Research Site | Lucenec, Slovakia |
Research Site | Namestovo, Slovakia |
Research Site | Piestany, Slovakia |
Research Site | Prievidza, Slovakia |
Research Site | Rimavska Sobota, Slovakia |
Research Site | Ruzomberok, Slovakia |
Research Site | Zilina, Slovakia |
Research Site | Verulam, Kwa Zulu Natal, South Africa |
Research Site | Cape Town, South Africa |
Research Site | Durban, South Africa |
Research Site | Johannesburg, South Africa |
Research Site | Umkomaas, South Africa |
Research Site | Chur, Graubunden, Switzerland |
Research Site | Basel, Switzerland |
Research Site | Bern, Switzerland |
Research Site | Geneva 14, Switzerland |
Research Site | Kreuzlingen, Switzerland |
Research Site | Lugano, Switzerland |
Research Site | Rorschach, Switzerland |
Research Site | Dnipropetrov'sk, Ukraine |
Research Site | Kiev, Ukraine |
Research Site | Vinnytsia, Ukraine |
Research Site | Vynnitsa, Ukraine |
Research Site | Zaporozhye, Ukraine |