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Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01294423
Enrollment
261
Registered
2011-02-11
Start date
2011-02-28
Completion date
2012-03-31
Last updated
2014-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Sugar, Type 2 Diabetes

Keywords

Phase3, Clinical trial, Type2 Diabetes Mellitus

Brief summary

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Interventions

DRUGDapagliflozin

Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose

DRUGPlacebo

Matching placebo for Dapagliflozin 5mg/10mg oral dose

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Provision of informed consent prior to any study specific procedures * Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Exclusion criteria

* Type 1 diabetes mellitus * FPG \>240 mg/dL before randomization * Subjects who have history of unstable or rapidly progressing renal disease * Subjects who have severe hepatic insufficiency and/or significant abnormal liver function * Significant cardiovascular history

Design outcomes

Primary

MeasureTime frameDescription
Adjusted Mean Change in HbA1c LevelsFrom Baseline to Week 24To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Secondary

MeasureTime frameDescription
Adjusted Mean Change in Fasting Plasma Glucose (FPG)From Baseline to Week 24To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Adjusted Mean Change in Body WeightFrom Baseline to Week 24To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Countries

Japan

Participant flow

Recruitment details

First participant enrolled: 25 Feb 2011. Last participant completed 24 week period: 12 Mar 2012. 354 participant were enrolled in 30 Japanese centers. 261 participants were randomized. Japanese men or women aged \>= 20 years with inadequate glycemic control (HbA1c 6.5% to 10.0%) with diet and exercise.

Pre-assignment details

Wash-out period was applicable only for participants with ongoing anti-diabetic treatment at enrolment. Drug-naive participants skip the period and directly proceed to a placebo lead-in period.

Participants by arm

ArmCount
Dapagliflozin 5 mg
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
86
Dapagliflozin 10 mg
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
88
Placebo
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
87
Total261

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event123
Overall Studypoor/non-compliance101
Overall Studysubject no longer meets study criteria252
Overall StudyWithdrawal by Subject122

Baseline characteristics

CharacteristicDapagliflozin 5 mgDapagliflozin 10 mgPlaceboTotal
Age, Continuous58.6 years
STANDARD_DEVIATION 10.41
57.5 years
STANDARD_DEVIATION 9.29
60.4 years
STANDARD_DEVIATION 9.65
58.9 years
STANDARD_DEVIATION 9.83
Age, Customized
65 - <75 years
23 participants20 participants29 participants72 participants
Age, Customized
< 65 years
59 participants67 participants55 participants181 participants
Age, Customized
>= 75 years
4 participants1 participants3 participants8 participants
Body Mass Index24.88 kg/m^2
STANDARD_DEVIATION 3.907
26.06 kg/m^2
STANDARD_DEVIATION 4.519
25.22 kg/m^2
STANDARD_DEVIATION 4.394
25.39 kg/m^2
STANDARD_DEVIATION 4.296
Body Weight65.81 kg
STANDARD_DEVIATION 14.371
69.70 kg
STANDARD_DEVIATION 13.821
65.96 kg
STANDARD_DEVIATION 12.908
67.17 kg
STANDARD_DEVIATION 13.777
FPG137.5 mg/dL
STANDARD_DEVIATION 24.41
138.8 mg/dL
STANDARD_DEVIATION 22.14
139.6 mg/dL
STANDARD_DEVIATION 21.63
138.6 mg/dL
STANDARD_DEVIATION 22.68
HbA1c7.50 Percent
STANDARD_DEVIATION 0.718
7.46 Percent
STANDARD_DEVIATION 0.608
7.50 Percent
STANDARD_DEVIATION 0.625
7.49 Percent
STANDARD_DEVIATION 0.649
Region of Enrollment
Japan
86 participants88 participants87 participants261 participants
Seated Systolic Blood Pressure122.0 mmHg
STANDARD_DEVIATION 13.01
126.2 mmHg
STANDARD_DEVIATION 12.46
126.5 mmHg
STANDARD_DEVIATION 14.36
124.9 mmHg
STANDARD_DEVIATION 13.41
Sex: Female, Male
Female
36 Participants35 Participants35 Participants106 Participants
Sex: Female, Male
Male
50 Participants53 Participants52 Participants155 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
11 / 8615 / 8814 / 87
serious
Total, serious adverse events
0 / 861 / 881 / 87

Outcome results

Primary

Adjusted Mean Change in HbA1c Levels

To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Time frame: From Baseline to Week 24

Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

ArmMeasureValue (LEAST_SQUARES_MEAN)
Dapagliflozin 5 mgAdjusted Mean Change in HbA1c Levels-0.41 Percent
Dapagliflozin 10 mgAdjusted Mean Change in HbA1c Levels-0.45 Percent
PlaceboAdjusted Mean Change in HbA1c Levels-0.06 Percent
Comparison: The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)p-value: <0.000195% CI: [-0.52, -0.18]ANCOVA
Comparison: The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)p-value: <0.000195% CI: [-0.56, -0.23]ANCOVA
Secondary

Adjusted Mean Change in Body Weight

To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Time frame: From Baseline to Week 24

Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

ArmMeasureValue (LEAST_SQUARES_MEAN)
Dapagliflozin 5 mgAdjusted Mean Change in Body Weight-2.13 kg
Dapagliflozin 10 mgAdjusted Mean Change in Body Weight-2.22 kg
PlaceboAdjusted Mean Change in Body Weight-0.84 kg
Comparison: The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0p-value: 0.000395% CI: [-1.98, -0.59]ANCOVA
Comparison: The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0p-value: 0.000195% CI: [-2.08, -0.69]ANCOVA
Secondary

Adjusted Mean Change in Fasting Plasma Glucose (FPG)

To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Time frame: From Baseline to Week 24

Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

ArmMeasureValue (LEAST_SQUARES_MEAN)
Dapagliflozin 5 mgAdjusted Mean Change in Fasting Plasma Glucose (FPG)-8.6 mg/dL
Dapagliflozin 10 mgAdjusted Mean Change in Fasting Plasma Glucose (FPG)-13.7 mg/dL
PlaceboAdjusted Mean Change in Fasting Plasma Glucose (FPG)5.8 mg/dL
Comparison: The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0p-value: <0.000195% CI: [-20.1, -8.7]ANCOVA
Comparison: The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0p-value: <0.000195% CI: [-25.2, -13.8]ANCOVA

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026