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
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
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
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014