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CompletedNCT00972244Updated Oct 14, 2013Results posted

Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients

A Phase 2 interventional study of Dapagliflozin and Placebo in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 20 sites in Japan. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2013-10-14.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
417
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 diabetes mellitus
  • Japanese
  • phase 2
  • efficacy
  • safety
  • dapagliflozin
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 417 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Japanese Subjects with type 2 diabetes mellitus.
  • Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
  • Provision of informed consent.

Exclusion criteria

Exclusion Criteria:

  • Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
  • The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
417 participants (actual)

Study arms

  • Experimental
    1

    1mg dapagliflozin

    Drug: Dapagliflozin

  • Experimental
    2

    2.5mg dapagliflozin

    Drug: Dapagliflozin

  • Experimental
    3

    5mg dapagliflozin

    Drug: Dapagliflozin

  • Experimental
    4

    10mg dapagliflozin

    Drug: Dapagliflozin

  • Placebo comparator
    5

    Placebo

    Drug: Placebo

Interventions

  • DrugDapagliflozin

    once daily, 12 weeks

  • DrugPlacebo

    once daily, 12 weeks

06

What researchers measure

Primary outcomes

  1. Adjusted Mean Change in HbA1c Levels

    The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Adjusted Mean Change in Fasting Plasma Glucose

    Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.

    Time frame: Baseline to Week 12

  2. Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

    Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin \<7%, after 12 weeks of double-blind therapy

    Time frame: At Week 12

07

Results

Posted Oct 14, 2013
Limitations and caveats
If an efficacy measurement was unavailable at the time point for analysis, last observation was carried forward (LOCF).

Participant flow

Enrollment: 417; randomized: 279 Study Start Date: August 2009 Study Completion Date: May 2010 Primary Completion Date: May 2010

Participant flow — Overall Study
Milestone1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlacebo
Started5956585254
Completed5451565245
Not completed55209
Withdrew: Incorrect enrolment10000
Withdrew: Adverse event01100
Withdrew: Subject no longer meets study criteria22005
Withdrew: Withdrawal by subject12101
Withdrew: Safety00001
Withdrew: Death10000
Withdrew: Various00002

Outcome measures

PrimaryAdjusted Mean Change in HbA1c Levels

The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.

Time frame:
Baseline to Week 12
Reported as:
Least squares mean · percent
Adjusted Mean Change in HbA1c Levels
percent1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlacebo
Adjusted Mean Change in HbA1c Levels-0.12 (-0.25 to 0.01)-0.10 (-0.24 to 0.04)-0.37 (-0.50 to -0.23)-0.44 (-0.58 to -0.29)0.35 (0.21 to 0.49)
Statistical analysis
  • 1mg Dapagliflozin vs Placebo · ANCOVA · p = <0.0001 (significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.) · Mean difference (final values): -0.47 · 95% CI -0.67 to -0.28with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.
  • 2.5mg Dapagliflozin vs Placebo · ANCOVA · p = <0.0001 (significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.) · Mean difference (final values): -0.45 · 95% CI -0.65 to -0.26with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.
  • 5mg Dapagliflozin vs Placebo · ANCOVA · p = <0.0001 (significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.) · Mean difference (final values): -0.72 · 95% CI -0.92 to -0.53with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.
  • 10mg Dapagliflozin vs Placebo · ANCOVA · p = <0.0001 (significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.) · Mean difference (final values): -0.79 · 95% CI -0.99 to -0.59with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.
SecondaryAdjusted Mean Change in Fasting Plasma Glucose

Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.

Time frame:
Baseline to Week 12
Reported as:
Least squares mean · mg/dL
Adjusted Mean Change in Fasting Plasma Glucose
mg/dL1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlacebo
Adjusted Mean Change in Fasting Plasma Glucose-16.63 (-23.25 to -10.00)-19.97 (-26.47 to -13.47)-23.49 (-30.06 to -16.93)-31.92 (-38.76 to -25.09)9.45 (2.82 to 16.08)
Statistical analysis
  • 1mg Dapagliflozin vs Placebo · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.) · Mean difference (final values): -26.08 · 95% CI -35.45 to -16.70with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.
  • 2.5mg Dapagliflozin vs Placebo · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.) · Mean difference (final values): -29.42 · 95% CI -38.70 to -20.14with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.
  • 5mg Dapagliflozin vs Placebo · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.) · Mean difference (final values): -32.94 · 95% CI -42.28 to -23.60with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.
  • 10mg Dapagliflozin vs Placebo · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.) · Mean difference (final values): -41.37 · 95% CI -50.90 to -31.85with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.
SecondaryProportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin \<7%, after 12 weeks of double-blind therapy

Time frame:
At Week 12
Reported as:
Number · Percentage of participants
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Percentage of participants1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlacebo
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%1.79.35.29.61.9
Statistical analysis
  • 1mg Dapagliflozin vs Placebo · Fisher Exact · p = 1.0000 (not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.) · Risk difference (rd): -0.2 · 95% CI -9.1 to 7.6
  • 2.5mg Dapagliflozin vs Placebo · Fisher Exact · p = 0.2057 (not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.) · Risk difference (rd): 7.3 · 95% CI -2.3 to 18.8
  • 5mg Dapagliflozin vs Placebo · Fisher Exact · p = 0.6203 (not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.) · Risk difference (rd): 3.2 · 95% CI -6.2 to 13.2
  • 10mg Dapagliflozin vs Placebo · Fisher Exact · p = 0.2050 (not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.) · Risk difference (rd): 7.7 · 95% CI -2.0 to 19.5

Adverse events

Collected over Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1mg Dapagliflozin—2/59 (3.4%)14/59 (23.7%)
2.5mg Dapagliflozin—1/56 (1.8%)13/56 (23.2%)
5mg Dapagliflozin—2/58 (3.4%)14/58 (24.1%)
10mg Dapagliflozin—1/52 (1.9%)13/52 (25%)
Placebo—0/54 (0%)14/54 (25.9%)
Most frequent serious events
Most frequent serious events
Event1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlacebo
GASTROENTERITISInfections and infestations0/590/560/581/520/54
BLADDER CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/591/560/580/520/54
ACUTE MYOCARDIAL INFARCTIONCardiac disorders0/590/561/580/520/54
DERMAL CYSTSkin and subcutaneous tissue disorders0/590/561/580/520/54
MULTI-ORGAN FAILUREGeneral disorders1/590/560/580/520/54
CHOLECYSTITISHepatobiliary disorders1/590/560/580/520/54
SEPSISInfections and infestations1/590/560/580/520/54
SPINAL COMPRESSION FRACTUREInjury, poisoning and procedural complications1/590/560/580/520/54
Most frequent other events
Most frequent other events
Event1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlacebo
NasopharyngitisInfections and infestations12/5910/567/5812/5213/54
EczemaSkin and subcutaneous tissue disorders0/590/560/580/523/54
HeadacheNervous system disorders0/593/562/581/520/54
Upper Respiratory Tract InflammationRespiratory, thoracic and mediastinal disorders1/590/563/580/520/54
ConstipationGastrointestinal disorders3/590/562/580/521/54

Baseline characteristics

Full Analysis Set defined as all randomised participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind period.

Age Continuous
Age Continuous(years)1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlaceboTotal
Mean55.9 ± 9.7357.7 ± 9.3358.0 ± 9.5056.5 ± 11.4758.4 ± 9.9757.3 ± 9.98
Sex: Female, Male
Sex: Female, Male(Participants)1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlaceboTotal
Female121711131164
Male4739473943215
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlaceboTotal
Japanese5956585254279
HBA1C
HBA1C(percent)1mg Dapagliflozin2.5mg Dapagliflozin5mg Dapagliflozin10mg DapagliflozinPlaceboTotal
Mean8.10 ± 0.7857.92 ± 0.7408.05 ± 0.6608.18 ± 0.6908.12 ± 0.7148.07 ± 0.720
08

Study locations

20 sites
  • Research Site
    Anjyo, Japan
  • Research Site
    Bunkyo-ku, Japan
  • Research Site
    Chuo-ku, Japan
  • Research Site
    Daito, Japan
  • Research Site
    Kamagaya, Japan
  • Research Site
    Kashiwara, Japan
  • Research Site
    Matsuyama, Japan
  • Research Site
    Nagoya, Japan
  • Research Site
    Nakano-ku, Japan
  • Research Site
    Naka, Japan
  • Research Site
    Nerima-ku, Japan
  • Research Site
    Okinawa, Japan
  • Research Site
    Osaka, Japan
  • Research Site
    Sapporo, Japan
  • Research Site
    Shibuya-ku, Japan
  • Research Site
    Shinjyuku-ku, Japan
  • Research Site
    Suita, Japan
  • Research Site
    Uji, Japan
  • Research Site
    Wakayama, Japan
  • Research Site
    Yamato, Japan
09

References and documents

Publications

  • Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19. PubMed 26894924 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00972244
Lead sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Sep 4, 2009
Start date
Aug 2009
Primary completion
May 2010
Completion
May 2010
Results posted
Oct 14, 2013
Last update
Oct 14, 2013

Study contacts

Parikh Shamik
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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