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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01159249

Collaborator

(none)

245

Enrollment

Locations

Arms

Duration (Months)

10.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Vildagliptin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

245 participants

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Open Met add-on vildagliptin	Drug: Vildagliptin
Other: Open TZD add-on vildagliptin	Drug: Vildagliptin
Other: Open α-GI add-on vildagliptin	Drug: Vildagliptin
Other: Glinides add-on vildagliptin	Drug: Vildagliptin

Outcome Measures

Primary Outcome Measures

Measure AEs, vital signs, laboratory evaluations [52 weeks]

Secondary Outcome Measures

HBA1c [52 weeks]
Fasting Plasma Glucose [52 weeks]
Fasting Insulin [52 weeks]
Fasting C-peptide [52 weeks]
HOMA-B [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Hunabashi	Chiba	Japan	274-0805
2	Novartis Investigative Site	Chikushino	Fukuoka	Japan	818-0036
3	Novartis Investigative Site	Itoshima-shi	Fukuoka	Japan	819-1102
4	Novartis Investigative Site	Koriyama	Fukushima	Japan	963-8851
5	Novartis Investigative Site	Kobe	Hyogo	Japan	658-0064
6	Novartis Investigative Site	Kawasaki	Kanagawa	Japan	210-0852
7	Novartis Investigative Site	Kawasaki	Kanagawa	Japan	212-0024
8	Novartis Investigative Site	Yokohama-city	Kanagawa	Japan	221-0077
9	Novartis Investigative Site	Yokohama	Kanagawa	Japan	221-0065
10	Novartis Investigative Site	Izumisano	Osaka	Japan	598-0048
11	Novartis Investigative Site	Hannou	Saitama	Japan	357-0024
12	Novartis Investigative Site	Hiki-Gun	Saitama	Japan	355-0328
13	Novartis Investigative Site	Kawaguchi	Saitama	Japan	332-0012
14	Novartis Investigative Site	Koshigaya city	Saitama	Japan	343-0826
15	Novartis Investigative Site	Tokorozawa	Saitama	Japan	359-1161
16	Novartis Investigative Site	Edogawa-ku	Tokyo	Japan	134-0084
17	Novartis Investigative Site	Hachioji	Tokyo	Japan	192-0046
18	Novartis Investigative Site	Katsushika-ku	Tokyo	Japan	125-0041
19	Novartis Investigative Site	Minato-ku	Tokyo	Japan	108-0075
20	Novartis Investigative Site	Shinagawa-ku	Tokyo	Japan	141-0032
21	Novartis Investigative Site	Toshima-ku	Tokyo	Japan	171-0021
22	Novartis Investigative Site	Fukuoka		Japan	807-0857
23	Novartis Investigative Site	Fukuoka		Japan	816-0094
24	Novartis Investigative Site	Fukuoka		Japan	819-0168