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Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

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ClinicalTrials.gov Identifier: NCT00728351
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin + metformin Drug: metformin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.
Study Start Date : June 2008
Actual Primary Completion Date : February 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: vildagliptin + metformin Drug: vildagliptin + metformin
Active Comparator: metformin Drug: metformin
1000 bid metformin


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. FPG reduction [ Time Frame: 24 weeks ]
  2. Safety and tolerability [ Time Frame: 24 weeks ]
  3. Body weight change from baseline [ Time Frame: 24 weeks ]
  4. Changes in the fasting lipid profile [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of T2DM treated with Metformin

Exclusion Criteria:

  • FPG >= 260 mg/dL (14.4mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728351


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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here for more information on the clinical study  This link exits the ClinicalTrials.gov site

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00728351     History of Changes
Other Study ID Numbers: CLMF237A2309
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 diabetes, vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action