| Trial ID: | L6223 |
| Source ID: | NCT00961909
|
| Associated Drug: |
Ro5095932
|
| Title: |
A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: RO5095932|DRUG: RO5095932|DRUG: metformin|DRUG: placebo
|
| Outcome Measures: |
Primary: Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs, monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up|Change in hemoglobin A1c (HbA1c), from baseline to week 6 | Secondary: Pharmacokinetics: blood concentration of RO5095932 after multiple dosing, multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up|Change in metabolic parameters: glucose, insulin, C-peptide, assessed after 4 or 6 weeks on study treatment
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
122
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: |Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-06
|
| Completion Date: |
2010-10
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-02
|
| Locations: |
Anaheim, California, 92801, United States|Chula Vista, California, 91911, United States|Ft. Myers, Florida, 33901, United States|Miramar, Florida, 33025, United States|San Antonio, Texas, 78209, United States|San Antonio, Texas, 78229-4801, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00961909
|
