| Trial ID: | L6844 |
| Source ID: | NCT02702011
|
| Associated Drug: |
Empagliflozin Medium Dose
|
| Title: |
Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02702011/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: empagliflozin medium dose|DRUG: empagliflozin low dose|DRUG: empagliflozin high dose|DRUG: placebo
|
| Outcome Measures: |
Primary: Change From Baseline in 24 Hour UGE on Day 7, Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication., Baseline and 7 days |
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-03-20
|
| Completion Date: |
2016-10-03
|
| Results First Posted: |
2018-04-02
|
| Last Update Posted: |
2018-04-02
|
| Locations: |
Souseikai Hakata Clinic, Fukuoka, Fukuoka, 812-0025, Japan|Nishikumamoto Hospital, Kumamoto, Kumamoto, 861-4157, Japan|Shinjuku Research Park Clinic, Tokyo, Shinjyuku-ku, 169-0073, Japan|SOUSEIKAI Sumida Hospital, Tokyo, Sumida-ku, 130-0004, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02702011
|
