Completed

Dapagliflozin Monotherapy for Improved Glycemic Control in Japanese Type 2 Diabetes Patients

Study Aim

This study aims to evaluate the effectiveness of Dapagliflozin as a standalone treatment in improving blood sugar control, measured by HbA1c levels, in Japanese patients with Type 2 Diabetes over a 24-week period.

What is being tested

Dapagliflozin

+ Placebo

Drug

Who is being recruted

Diabetes Mellitus+4

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 20 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: February 2011

See protocol details

Summary

Principal SponsorAstraZeneca

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2011

Actual date on which the first participant was enrolled.

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.

Official TitleA 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

NCT01294423

Principal SponsorAstraZeneca

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

261 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperglycemiaMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate

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

5 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Dapagliflozin 5 mg

Group II

Experimental

Dapagliflozin 10 mg

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 26 locations

Suspended

Research Site

Noda, JapanOpen Research Site in Google Maps

Suspended

Research Site

Fukuoka, Japan

Suspended

Research Site

Yukuhashi, Japan

Suspended

Research Site

Hiroshima, Japan

Completed26 Study Centers