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

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: NCT00101712
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : May 7, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin Drug: Vildagliptin Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
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
Study Start Date : October 2004
Primary Completion Date : May 2006
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vildagliptin Drug: vildagliptin
Other Name: LAF237
Placebo Comparator: Placebo Drug: Vildagliptin Placebo


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: January 13, 2005    Key Record Dates
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