| Trial ID: | L5926 |
| Source ID: | NCT02737891
|
| Associated Drug: |
Tesofensine/Metoprolol
|
| Title: |
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02737891/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Tesofensine/Metoprolol|DRUG: Placebo
|
| Outcome Measures: |
Primary: Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate, 24-hour heart rate monitoring was based on telemetry measurements at baseline (Day -1 to 1, V2) and at the end of treatment (Day 90 to 91, V10). The heart rate was measured every minute and the mean was recorded for every hour., Baseline to Day 90 | Secondary: Change From Baseline to End of Treatment in HbA1c, HbA1c was measured from blood samples collected at baseline (Day 1, V2) and at the end of treatment (Day 90, V10). Additional HbA1c measurements were done during various visits (V6, V8 and V12)., Baseline to Day 90|Change From Baseline to End of Treatment in Body Weight, Change in kg body weight measured from baseline to day 90, Baseline to Day 90
|
| Sponsor/Collaborators: |
Sponsor: Saniona | Collaborators: Profil Institut für Stoffwechselforschung GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-04
|
| Completion Date: |
2017-03
|
| Results First Posted: |
2020-05-14
|
| Last Update Posted: |
2020-05-14
|
| Locations: |
Profil Institut für Stoffwechselforschung GmbH, Neuss, D-41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02737891
|
