JRCT ID: jRCT2080220768
Registered date:07/07/2009
Basic Information
Recruitment status | |
---|---|
Health condition(s) or Problem(s) studied | Type 2 Diabetes |
Date of first enrollment | 07/07/2009 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
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 |
Gender | Both |
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
Primary Sponsor | AstraZeneca |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-090796 |
Contact
Public contact | |
Name | |
Address | RD-clinical-information-Japan@astrazeneca.com |
Telephone | |
Affiliation | AstraZeneca KK |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |