| Trial ID: | L5616 |
| Source ID: | NCT01152385
|
| Associated Drug: |
Azd1656
|
| Title: |
Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01152385/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: AZD1656|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Haemoglobin A1c (HbA1c), from baseline to 4 months | Secondary: Change in Fasting Plasma Glucose (FPG), from baseline to 4 months|Number of Responders in Terms of HbA1C ≤ 7%, at 4th month|Number of Responders in Terms of HbA1C ≤ 6.5%, at 4th month|Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C), from baseline to 4 months|Percentage Change in High-density Lipoprotein Cholesterol (HDL-C), from baseline to 4 months|Percentage Change in Triglycerides, from baseline to 4 months|Change in High-sensitivity C-reactive Protein (Hs-CRP), from baseline to 4 months
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
224
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-05
|
| Completion Date: |
2011-05
|
| Results First Posted: |
2012-08-27
|
| Last Update Posted: |
2012-08-27
|
| Locations: |
Research Site, Osaka, Japan|Research Site, Suita, Japan|Research Site, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01152385
|
