NCT00972244

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P75+ for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

20 active sites

Status
completed

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

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

October 14, 2013

Completed
Last Updated

October 14, 2013

Status Verified

August 1, 2013

Enrollment Period

9 months

First QC Date

August 31, 2009

Results QC Date

January 21, 2013

Last Update Submit

August 9, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitusJapanesephase 2efficacysafetydapagliflozin

Outcome Measures

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.

    Baseline to Week 12

Secondary Outcomes (2)

  • Adjusted Mean Change in Fasting Plasma Glucose

    Baseline to Week 12

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

    At Week 12

Study Arms (5)

1

EXPERIMENTAL

1mg dapagliflozin

Drug: Dapagliflozin

2

EXPERIMENTAL

2.5mg dapagliflozin

Drug: Dapagliflozin

3

EXPERIMENTAL

5mg dapagliflozin

Drug: Dapagliflozin

4

EXPERIMENTAL

10mg dapagliflozin

Drug: Dapagliflozin

5

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DapagliflozinDRUG

once daily, 12 weeks

1234
PlaceboDRUG

once daily, 12 weeks

5

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

Anjyo, Japan

Location

Research Site

Bunkyō City, Japan

Location

Research Site

Chūōku, Japan

Location

Research Site

Daitō, Japan

Location

Research Site

Kamagaya, Japan

Location

Research Site

Kashiwara, Japan

Location

Research Site

Matsuyama, Japan

Location

Research Site

Nagoya, Japan

Location

Research Site

Naka, Japan

Location

Research Site

Nakano, Japan

Location

Research Site

Nerima-ku, Japan

Location

Research Site

Okinawa, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Sapporo, Japan

Location

Research Site

Shibuya-ku, Japan

Location

Research Site

Shinjyuku-ku, Japan

Location

Research Site

Suita, Japan

Location

Research Site

Uji, Japan

Location

Research Site

Wakayama, Japan

Location

Research Site

Yamato, Japan

Location

Related Publications (1)

  • 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.

    PMID: 26894924DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

If an efficacy measurement was unavailable at the time point for analysis, last observation was carried forward (LOCF).

Results Point of Contact

Title
Eva Johnsson
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Parikh Shamik

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 4, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 14, 2013

Results First Posted

October 14, 2013

Record last verified: 2013-08

Locations

JP(20)