| Trial ID: | L6719 |
| Source ID: | NCT00970528
|
| Associated Drug: |
Acarbose (Glucobay, Bayg5421)
|
| Title: |
Glucose Reduction by Early Acarbose Treatment in Basal Insulin
|
| Acronym: |
GREAN
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Acarbose (Glucobay, BAYG5421)|DRUG: Voglibose (Basen)
|
| Outcome Measures: |
Primary: Glycosylated hemoglobin (HbA1c), Change from baseline to week 24, at week -2, 0, 8 and 24 | Secondary: Self monitoring blood glucose concentration, 6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)|Fasting blood glucose concentration, At week -2, 0, 4, 8, 16 and 24|Blood concentration of triglyceride, At week -2 and 24|Blood concentration of low density lipoprotein, At week -2 and 24|Blood concentration of total cholesterol, At week -2 and 24|Blood concentration of high density lipoprotein, At week -2 and 24|Blood concentration of apolipoprotein A-1, At week -2 and 24|Blood concentration of apolipoprotein B, At week -2 and 24|Blood concentration of Glucagon-like peptide-1 (GLP-1), At week -0 and 24|Body weight, Body Mass Index(BMI), At week -2, 0, 4, 8, 16 and 24|High Sensitivity C-reactive protein (hs-CRP), At week -2 and 24
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
124
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-11
|
| Completion Date: |
2012-03
|
| Results First Posted: |
|
| Last Update Posted: |
2014-02-20
|
| Locations: |
Wonju-si, Gang''weondo, 220-701, Korea, Republic of|Busan, Korea, 602-714, Korea, Republic of|Gyeonggi-do, Korea, 463-500, Korea, Republic of|Gyeonggi-do, Korea, 471-701, Korea, Republic of|Pusan, Korea, 602-739, Korea, Republic of|Seoul, Korea, 150-713, Korea, Republic of|Daegu, 705-717, Korea, Republic of|Jeonju-si, 456-712, Korea, Republic of|Seongbuk-gu Seoul, 136-705, Korea, Republic of|Seoul, 134-701, Korea, Republic of|Seoul, 135-710, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00970528
|
