Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Vildagliptin 100 mg qd
Drug: Metformin 1500 mg daily
PhasePhase 3
SponsorNovartis Pharmaceuticals
Responsible PartyNovartis
ClinicalTrials.gov IdentifierNCT00383578
First ReceivedSeptember 29, 2006
Last UpdatedJanuary 2, 2013
Last verifiedJanuary 2013

Tracking Information[ + expand ][ + ]

First Received DateSeptember 29, 2006
Last Updated DateJanuary 2, 2013
Start DateSeptember 2006
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresChange from baseline in HbA1c [Time Frame: after 24 weeks of treatment] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Adverse event profile [Time Frame: after 24 weeks of treatment] [Designated as safety issue: Yes]
  • Gastrointestinal tolerability [Time Frame: after 24 weeks of treatment] [Designated as safety issue: No]
  • Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7% [Time Frame: after 24 weeks of treatment] [Designated as safety issue: No]
  • Change from baseline in fasting plasma glucose [Time Frame: after 24 weeks of treatment] [Designated as safety issue: No]
  • Change from baseline in body weight [Time Frame: after 24 weeks of treatment] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes
Official TitleA Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes
Brief Summary
This study is designed to demonstrate the efficacy and safety of vildagliptin compared to
metformin in elderly drug naive patients with type 2 diabetes
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Vildagliptin 100 mg qd
Drug: Metformin 1500 mg daily
Study Arm (s)
  • Experimental: Vildagliptin
  • Active Comparator: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment335
Estimated Completion DateNot Provided
Estimated Primary Completion DateMay 2008
Eligibility Criteria
Inclusion Criteria:

- Age from 65 years to the upper age limit recommended by local prescribing information
for metformin

- Drug naive patients with type 2 diabetes.

- Body mass index (BMI) in the range of 22-40 kg/m2.

- HbA1c in the range of 7 to 9% inclusive

- FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

- A history of type 1 diabetes

- Evidence of significant diabetic complications

- Treatment with insulin or any other oral antidiabetic agents

Other protocol-defined inclusion/exclusion criteria may apply
GenderBoth
Ages65 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesGermany, Switzerland

Administrative Information[ + expand ][ + ]

NCT Number NCT00383578
Other Study ID NumbersCLAF237A2398
Has Data Monitoring CommitteeNot Provided
Information Provided ByNovartis
Study SponsorNovartis Pharmaceuticals
CollaboratorsNot Provided
Investigators Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification DateJanuary 2013

Locations[ + expand ][ + ]

Investigative Centers
Nurnberg, Germany
Novartis Pharmaceuticals
Basel, Switzerland