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Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00101712
First Posted: January 13, 2005
Last Update Posted: May 7, 2012
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin Drug: Vildagliptin Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures:
  • Adverse event profile after 52 weeks of treatment
  • Patients with HbA1c <6.5% at 12 weeks
  • Patients with HbA1c <6.5% at 52 weeks
  • Change from baseline in fasting plasma glucose at 52 weeks
  • Coefficient of failure for HbA1c between 24 weeks and 52 weeks

Enrollment: 274
Study Start Date: October 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Drug: vildagliptin
Other Name: LAF237
Placebo Comparator: Placebo Drug: Vildagliptin Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Blood glucose criteria must be met
  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 22-45
  • Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion Criteria:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of serious diabetic complications
  • Evidence of serious cardiovascular complications
  • Significant laboratory abnormalities as defined by the protocol
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
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): NCT00101712


Locations
Germany
Novartis Investigative Site
Investigative Site, Germany
Switzerland
Novartis Investigative Site
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00101712     History of Changes
Other Study ID Numbers: CLAF237A2307
First Submitted: January 12, 2005
First Posted: January 13, 2005
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
type 2 diabetes
vildagliptin

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