| Trial ID: | L2515 |
| Source ID: | NCT02401880
|
| Associated Drug: |
Linagliptin
|
| Title: |
Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Linagliptin|OTHER: Placebo|DRUG: Empagliflozin
|
| Outcome Measures: |
Primary: • Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo), 30 days | Secondary: • Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3), 30 days
|
| Sponsor/Collaborators: |
Sponsor: Profil Institut für Stoffwechselforschung GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
89
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2015-05
|
| Completion Date: |
2015-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-02-24
|
| Locations: |
Profil Mainz GmbH & Co. KG, Mainz, 55116, Germany|Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02401880
|