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Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00120536
Recruitment Status : Completed
First Posted : July 18, 2005
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
Study Start Date : June 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change from baseline in HbA1c at 24 weeks

Secondary Outcome Measures :
  1. Adverse event profile after 24 weeks of treatment
  2. Change from baseline in fasting plasma glucose at 24 weeks
  3. Patients with endpoint HbA1c < 7% after 24 weeks
  4. Patients with reduction in HbA1c >/= 0.7% after 24 weeks
  5. Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of type 1 diabetes
  • Evidence of significant diabetic complications
  • Serious cardiovascular events within the past 6 months
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined 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): NCT00120536


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00120536     History of Changes
Other Study ID Numbers: CLAF237A2384
First Posted: July 18, 2005    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
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