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Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159249
First Posted: July 9, 2010
Last Update Posted: June 15, 2015
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 designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

Condition Intervention Phase
Type 2 Diabetes Drug: Vildagliptin Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes

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

Primary Outcome Measures:
  • Measure AEs, vital signs, laboratory evaluations [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • HBA1c [ Time Frame: 52 weeks ]
  • Fasting Plasma Glucose [ Time Frame: 52 weeks ]
  • Fasting Insulin [ Time Frame: 52 weeks ]
  • Fasting C-peptide [ Time Frame: 52 weeks ]
  • HOMA-B [ Time Frame: 52 weeks ]

Enrollment: 245
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open Met add-on vildagliptin Drug: Vildagliptin
Open TZD add-on vildagliptin Drug: Vildagliptin
Open α-GI add-on vildagliptin Drug: Vildagliptin
Glinides add-on vildagliptin Drug: Vildagliptin

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

Inclusion Criteria:

  • patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
  • Age in the 20 years or over inclusive
  • HbA1c in the range of ≥ 6.5 to ≤ 10%

Exclusion Criteria:

  • Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases
  • Significant diabetic complications
  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): NCT01159249


Locations
Japan
Novartis Investigative Site
Hunabashi, Chiba, Japan, 274-0805
Novartis Investigative Site
Chikushino, Fukuoka, Japan, 818-0036
Novartis Investigative Site
Itoshima-shi, Fukuoka, Japan, 819-1102
Novartis Investigative Site
Koriyama, Fukushima, Japan, 963-8851
Novartis Investigative Site
Kobe, Hyogo, Japan, 658-0064
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 210-0852
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 212-0024
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 221-0077
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 221-0065
Novartis Investigative Site
Izumisano, Osaka, Japan, 598-0048
Novartis Investigative Site
Hannou, Saitama, Japan, 357-0024
Novartis Investigative Site
Hiki-Gun, Saitama, Japan, 355-0328
Novartis Investigative Site
Kawaguchi, Saitama, Japan, 332-0012
Novartis Investigative Site
Koshigaya city, Saitama, Japan, 343-0826
Novartis Investigative Site
Tokorozawa, Saitama, Japan, 359-1161
Novartis Investigative Site
Edogawa-ku, Tokyo, Japan, 134-0084
Novartis Investigative Site
Hachioji, Tokyo, Japan, 192-0046
Novartis Investigative Site
Katsushika-ku, Tokyo, Japan, 125-0041
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 108-0075
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 141-0032
Novartis Investigative Site
Toshima-ku, Tokyo, Japan, 171-0021
Novartis Investigative Site
Fukuoka, Japan, 807-0857
Novartis Investigative Site
Fukuoka, Japan, 816-0094
Novartis Investigative Site
Fukuoka, Japan, 819-0168
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01159249     History of Changes
Other Study ID Numbers: CLAF237A1308
First Submitted: July 7, 2010
First Posted: July 9, 2010
Last Update Posted: June 15, 2015
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety

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