Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
NCT01871558 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2016-04-21
Summary
To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.
Conditions
- Type 2 Diabetes Mellitus (T2DM)
Interventions
- DRUG
-
Vildagliptin
50 mg b.i.d
- DRUG
-
metformin is to be kept unchanged
- DRUG
-
sulfonylurea (SU)
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2015-02-28
- Completion
- 2015-02-28
Countries
- France
Study Locations
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