| Trial ID: | L5294 |
| Source ID: | NCT00646542
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Placebo
|
| Outcome Measures: |
Primary: To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment, 24 weeks | Secondary: To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency., 24 weeks|To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency., 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
525
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-03
|
| Completion Date: |
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| Results First Posted: |
|
| Last Update Posted: |
2020-12-17
|
| Locations: |
Buenos Aires, Argentina|Heidelberg Heights, Australia|Winnipeg, Canada|Cartago, Costa Rica|Tampere, Finland|Angers, France|Dormagen, Germany|Chennai, India|Oslo, Norway|Saint Petersburg, Russian Federation|Alicante, Spain|Lund, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT00646542
|
