Status:
COMPLETED
Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously us...
Eligibility Criteria
Inclusion
- T2DM patients inadequately controlled with metformin+ SU combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken
- with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization
- with a glycemic target of HbA1c \<= 7%
- with HbA1c at inclusion \>7% and \<=9%
- Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG)
Exclusion
- contraindication for either SUs, metformin or insulin and history of hypersensitivity to vildagliptin
- acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk
- Other protocol defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01871558
Start Date
June 1 2013
End Date
February 1 2015
Last Update
April 21 2016
Active Locations (19)
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1
Novartis Investigative Site
Antibes, France, 06600
2
Novartis Investigative Site
Auxerre, France, 89000
3
Novartis Investigative Site
Bar-le-Duc, France, 55012
4
Novartis Investigative Site
Bondy, France, 93143