| Trial ID: | L3387 |
| Source ID: | NCT02164266
|
| Associated Drug: |
Placebo
|
| Title: |
A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy Volunteer, Type 2 Diabetes
|
| Interventions: |
DRUG: Placebo|DRUG: RO6799477
|
| Outcome Measures: |
Primary: Incidence of adverse events (AEs), Up to 9 weeks | Secondary: Pharmacokinetic parameters derived from plasma and urine concentrations of RO6799477, area under the concentration time curve (AUC), Cmax, Day 1 and Day 14|Fasting serum glucose, Up to 9 weeks|Fasting serum insulin (Part 2 only), Up to 9 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-06
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-14
|
| Locations: |
Leiden, 2333, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT02164266
|
