Status:
COMPLETED
Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.
Eligibility Criteria
Inclusion
- Patients who sign the informed consent
- HbA1c in the range of \> 7 to ≤10.5% at Visit 1
- Ability to comply with all study requirements
Exclusion
- Pregnant or lactating women
- Serious cardiovascular disorders
- Liver/renal disease or dysfunction
- Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin
- Laboratories values abnormalities as defined by the protocol
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01426802
Start Date
October 1 2010
End Date
April 1 2011
Last Update
February 27 2017
Active Locations (1)
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1
Investigative site
Cairo, Egypt