| Trial ID: | L2781 |
| Source ID: | NCT01183104
|
| Associated Drug: |
Sitagliptin
|
| Title: |
START-J: SiTAgliptin in eldeRly Trial in Japan
|
| Acronym: |
START-J
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01183104/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Glimepiride
|
| Outcome Measures: |
Primary: Change From Baseline in HbA1c at 52 W, Baseline and 52 W|Number of Participants With Hypoglycaemia, From baseline to 52 W | Secondary: The Number of Participants Achieving HbA1c < 6.9 %, 52 W|Change From Baseline in HOMA-β at 52 W, β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = \[20 x fasting insulin (μU/mL)\] / \[fasting plasma glucose (mmol/L) - 3.5\], Baseline and 52 W|Change From Baseline in Insulin/Proinsulin Ratio at 52 W, Baseline and 52 W|Change From Baseline in Body Weight at 52 W, Baseline and 52 W
|
| Sponsor/Collaborators: |
Sponsor: Japan Association for Diabetes Education and Care | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
305
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-08
|
| Completion Date: |
2015-01
|
| Results First Posted: |
2017-04-14
|
| Last Update Posted: |
2017-04-14
|
| Locations: |
Japan Association for Diabetes Education and Care, Chiyoda-Ku, Tokyo, 102-0083, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01183104
|
