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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01159249
First received: July 7, 2010
Last updated: May 6, 2012
Last verified: May 2012
  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: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure AEs, vital signs, laboratory evaluations [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HBA1c [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Fasting Insulin [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Fasting C-peptide [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • HOMA-B [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 212-0024
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 210-0852
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 221-0065
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 221-0077
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, 819-0168
Novartis Investigative Site
Fukuoka, Japan, 816-0094
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01159249     History of Changes
Other Study ID Numbers: CLAF237A1308
Study First Received: July 7, 2010
Last Updated: May 6, 2012
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on September 16, 2014