Evaluation of Dapagliflozin Taken Twice-daily
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
1 other identifier
interventional
400
7 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Nov 2010
Shorter than P25 for phase_3 type-2-diabetes
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2010
CompletedFirst Posted
Study publicly available on registry
October 8, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
November 1, 2013
CompletedOctober 27, 2014
October 1, 2014
9 months
October 7, 2010
January 21, 2013
October 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change in HbA1c Levels
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.
Baseline to Week 16
Secondary Outcomes (4)
Adjusted Percent Change in Body Weight
Baseline to Week 16
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1
Baseline to Week 1
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
Baseline to Week 16
Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.
Baseline to Week 16
Study Arms (4)
1
EXPERIMENTALDapagliflozin 2.5 mg twice-daily plus open-label metformin
2
EXPERIMENTALDapagliflozin 5.0 mg twice-daily plus open-label metformin
3
EXPERIMENTALDapagliflozin 10 mg once-daily plus open-label metformin
4
PLACEBO COMPARATORPlacebo plus open-label metformin
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (55)
Research Site
Aßlar, Germany
Research Site
Berlin, Germany
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Biberach A.d. Riss, Germany
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Bosenheim, Germany
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Dippoldiswalde, Germany
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Falkensee, Germany
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Meissen, Germany
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München, Germany
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Neuwied, Germany
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Pirna, Germany
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Wahlstedt, Germany
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Balatonfüred, Hungary
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Budapest, Hungary
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Csongrád, Hungary
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Debrecen, Hungary
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Gyöngyös, Hungary
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Kecskemét, Hungary
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Makó, Hungary
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Nyíregyháza, Hungary
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Tát, Hungary
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Zalaegerszeg, Hungary
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Brasov, Brașov County, Romania
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Bucharest, Romania
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Iași, Romania
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Sibiu, Romania
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Suceava, Romania
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Dolný Kubín, Slovakia
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Košice, Slovakia
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Lučenec, Slovakia
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Námestovo, Slovakia
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Piešťany, Slovakia
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Prievidza, Slovakia
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Rimavská Sobota, Slovakia
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Ružomberok, Slovakia
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Žilina, Slovakia
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Verulam, KwaZulu-Natal, South Africa
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Cape Town, South Africa, South Africa
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Durban, South Africa, South Africa
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eMkhomazi, South Africa, South Africa
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Johannesburg, South Africa, South Africa
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Durban, South Africa
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Chur, Kanton Graubünden, Switzerland
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Basel, Switzerland
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Bern, Switzerland
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Geneva, Switzerland
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Kreuzlingen, Switzerland
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Lugano, Switzerland
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Rorschach, Switzerland
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Vynnitsa, Ukraine, Ukraine
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Zaporizhzhya, Ukraine, Ukraine
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Dnipropetrov'sk, Ukraine
Research Site
Kiev, Ukraine
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Vinnytsia, Ukraine
Related Publications (1)
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.
PMID: 25200570BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
For participants who did not complete 16 weeks LOCF (last observation carried forward) was used.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Shamik Parikh
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2010
First Posted
October 8, 2010
Study Start
November 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
October 27, 2014
Results First Posted
November 1, 2013
Record last verified: 2014-10