Trials / Completed
CompletedNCT01238978
Phase 4 Study in the Elderly Patients With T2DM
A Multicenter, Prospective, Randomized, Open-label, Parallel Group Study to Investigate the Clinical Benefit on Hypoglycemia Frequency of 24 Weeks Treatment With Galvus Versus Usual Care (Any OAD of Another Class Added to Metformin Within SmPc) in Older Patients With Type 2 Diabetes Insufficiently Controlled by Metformin Monotherapy.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 65 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vildagliptin | |
| DRUG | "Usual Care" |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2010-11-11
- Last updated
- 2017-02-23
Locations
15 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01238978. Inclusion in this directory is not an endorsement.