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A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

NCT01095653•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
•Drug naive or treated with anti-diabetic medication for \< 24 weeks
•C-peptide ≥ 1.0 ng/mL
•Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria

•AST and/or ALT \> 3 times ULN
•Serum total bilirubin \> 2 mg/dL
•Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
•Creatine kinase ≥ 3 times ULN
•Symptoms of severely uncontrolled diabetes
•Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Locations (39)

Local Institution

Hefei, Anhui, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Chongqing, Chongqing Municipality, China

Local Institution

Guanzhou, Guangdong, China

Local Institution

Wuhan, Hubei, China

Local Institution

Changsha, Hunan, China

Local Institution

Changsha, Hunan, China

Key Dates

Start Date

June 1, 2010

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

February 6, 2017

Enrollment

1,179

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Dapagliflozin

DRUG

Dapagliflozin

DRUG

Metformin

DRUG

Dapagliflozin Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D

Closed-loop in Adults With Type 2 Diabetes