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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00383578
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Vildagliptin 100 mg qd Drug: Metformin 1500 mg daily Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 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
Study Start Date : September 2006
Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vildagliptin Drug: Vildagliptin 100 mg qd
Active Comparator: Metformin Drug: Metformin 1500 mg daily



Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: after 24 weeks of treatment ]

Secondary Outcome Measures :
  1. Adverse event profile [ Time Frame: after 24 weeks of treatment ]
  2. Gastrointestinal tolerability [ Time Frame: after 24 weeks of treatment ]
  3. Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7% [ Time Frame: after 24 weeks of treatment ]
  4. Change from baseline in fasting plasma glucose [ Time Frame: after 24 weeks of treatment ]
  5. Change from baseline in body weight [ Time Frame: after 24 weeks of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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): NCT00383578


Locations
Germany
Investigative Centers
Nurnberg, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00383578     History of Changes
Other Study ID Numbers: CLAF237A2398
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 diabetes
vildagliptin
hemoglobin A1c
metformin

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