NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080220768

Registered date:07/07/2009

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType 2 Diabetes
Date of first enrollment07/07/2009
Target sample size
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : AZD1656 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Three increasing dose-steps with oral suspension control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo oral suspension

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 30age old
Age maximum<= 75age old
GenderBoth
Include criteria- A body mass index (BMI) of 18 to 27 kg/m2. - Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.
Exclude criteria- Renal dysfunction GFR <60mL/min. - Systolic pressure (SBP) >160mmHg or diastolic pressure (DBP) >95mmHg. - Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP. - History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.

Related Information

Contact

Public contact
Name
Address RD-clinical-information-Japan@astrazeneca.com
Telephone
E-mail
Affiliation AstraZeneca KK
Scientific contact
Name
Address
Telephone
E-mail
Affiliation