| Trial ID: | L1850 |
| Source ID: | NCT00390520
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin
|
| Outcome Measures: |
Primary: Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment | Secondary: Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment|The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment|Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose|Safety based primarily on frequency of adverse events, number of notable abnormal laboratory values, and frequency and severity of hypoglycemic events
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
28
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2007-09
|
| Results First Posted: |
|
| Last Update Posted: |
2020-02-11
|
| Locations: |
Novartis, Basel, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00390520
|
