Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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 June 17, 2013