Status:
COMPLETED
Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
Lead Sponsor:
Novartis
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
Eligibility Criteria
Inclusion
- Inclusion criteria
- Confirmed diagnosis of T2DM by standard criteria.
- Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
- Age: ≥18 to ≤ 80 years
- HbA1c of ≥ 7.5 and ≤ 11.0%
- Body Mass Index (BMI) ≥22 to ≤45 kg/m2
- Exclusion criteria:
- FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT01233622
Start Date
October 1 2010
End Date
November 1 2011
Last Update
February 23 2017
Active Locations (55)
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1
Novartis Investigative Site
Box Hill, Australia
2
Novartis Investigative Site
Heidelberg, Australia
3
Novartis Investigative Site
Parkville, Australia
4
Novartis Investigative Site
St Leonards, Australia