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.
ConditionType 2 Diabetes
InterventionDrug: dapagliflozin
Drug: dapagliflozin
Drug: dapagliflozin
Drug: metformin
Drug: placebo
PhasePhase 3
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT01217892
First ReceivedOctober 7, 2010
Last UpdatedOctober 31, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateOctober 7, 2010
Last Updated DateOctober 31, 2013
Start DateNovember 2010
Estimated Primary Completion DateAugust 2011
Current Primary Outcome MeasuresAdjusted 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
  • Adjusted Percent Change in Body Weight [Time Frame: Baseline to Week 16] [Designated as safety issue: No]To compare the percent change from baseline in body weight 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.
  • Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1 [Time Frame: Baseline to Week 1] [Designated as safety issue: No]To compare the change from baseline in fasting plasma glucose (FPG) 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 1 week of double-blind treatment.
  • Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16 [Time Frame: Baseline to Week 16] [Designated as safety issue: No]To compare the change from baseline in fasting plasma glucose (FPG) 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.
  • Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline. [Time Frame: Baseline to Week 16] [Designated as safety issue: No]To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% 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, in patients who had HbA1c ≥7.0% at baseline.

Descriptive Information[ + expand ][ + ]

Brief TitleEvaluation of Dapagliflozin Taken Twice-daily
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: 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)
  • Experimental: 1
    Dapagliflozin 2.5 mg twice-daily plus open-label metformin
  • Experimental: 2
    Dapagliflozin 5.0 mg twice-daily plus open-label metformin
  • Experimental: 3
    Dapagliflozin 10 mg once-daily plus open-label metformin
  • Placebo Comparator: 4
    Placebo plus open-label metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment400
Estimated Completion DateAugust 2011
Estimated Primary Completion DateAugust 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesGermany, Hungary, Romania, Slovakia, South Africa, Switzerland, Ukraine

Administrative Information[ + expand ][ + ]

NCT Number NCT01217892
Other Study ID NumbersD1691C00003
Has Data Monitoring CommitteeNo
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsBristol-Myers Squibb
Investigators Study Director: Shamik Parikh AstraZeneca
Verification DateOctober 2013

Locations[ + expand ][ + ]

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
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