Clinical trial NCT01159249: Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes
Official title: A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 245
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Measure AEs, vital signs, laboratory evaluations
timeFrame: 52 weeks
Secondary outcomes:
measure: HBA1c
timeFrame: 52 weeks
measure: Fasting Plasma Glucose
timeFrame: 52 weeks
measure: Fasting Insulin
timeFrame: 52 weeks
measure: Fasting C-peptide
timeFrame: 52 weeks
measure: HOMA-B
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hunabashi
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Chikushino
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Itoshima-shi
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Koriyama
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Izumisano
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Hannou
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hiki-Gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kawaguchi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Koshigaya city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals Corporation
role: STUDY_DIRECTOR
References: