| Trial ID: | L7339 |
| Source ID: | NCT01969747
|
| Associated Drug: |
Empagliflozin Medium Placebo
|
| Title: |
Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01969747/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Empagliflozin medium placebo|DRUG: Empagliflozin low placebo|DRUG: Empagliflozin low placebo|DRUG: Empagliflozin high placebo|DRUG: Empagliflozin medium|DRUG: Empagliflozin medium placebo|DRUG: Empagliflozin high placebo|DRUG: Empagliflozin high placebo|DRUG: Empagliflozin medium placebo|DRUG: Empagliflozin low placebo|DRUG: Empagliflozin low|DRUG: Empagliflozin high
|
| Outcome Measures: |
Primary: Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo, Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo. The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model. The primary endpoint is exploratory., baseline (Day -1) and 7 days after first drug administration (Day 7) |
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
75
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-11
|
| Completion Date: |
2014-04
|
| Results First Posted: |
2015-04-08
|
| Last Update Posted: |
2015-04-08
|
| Locations: |
1245.78.43001 Boehringer Ingelheim Investigational Site, Graz, Austria|1245.78.49001 Boehringer Ingelheim Investigational Site, Neuss, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01969747
|
