MedDataX Logo

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

NCT ID: NCT00972244

Last Updated: 2013-10-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Type 2 diabetes mellitus Japanese phase 2 efficacy safety dapagliflozin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

1mg dapagliflozin

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

once daily, 12 weeks

2

2.5mg dapagliflozin

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

once daily, 12 weeks

3

5mg dapagliflozin

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

once daily, 12 weeks

4

10mg dapagliflozin

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

once daily, 12 weeks

5

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once daily, 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin

once daily, 12 weeks

Intervention Type DRUG

Placebo

once daily, 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Parikh Shamik

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Anjyo, , Japan

Site Status

Research Site

Bunkyō City, , Japan

Site Status

Research Site

Chūōku, , Japan

Site Status

Research Site

Daitō, , Japan

Site Status

Research Site

Kamagaya, , Japan

Site Status

Research Site

Kashiwara, , Japan

Site Status

Research Site

Matsuyama, , Japan

Site Status

Research Site

Nagoya, , Japan

Site Status

Research Site

Naka, , Japan

Site Status

Research Site

Nakano, , Japan

Site Status

Research Site

Nerima-ku, , Japan

Site Status

Research Site

Okinawa, , Japan

Site Status

Research Site

Osaka, , Japan

Site Status

Research Site

Sapporo, , Japan

Site Status

Research Site

Shibuya-ku, , Japan

Site Status

Research Site

Shinjyuku-ku, , Japan

Site Status

Research Site

Suita, , Japan

Site Status

Research Site

Uji, , Japan

Site Status

Research Site

Wakayama, , Japan

Site Status

Research Site

Yamato, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26894924 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1692C00005

Identifier Type: -

Identifier Source: org_study_id