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

NCT ID: NCT01159249

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Met add-on vildagliptin

Group Type OTHER

Vildagliptin

Intervention Type DRUG

Open TZD add-on vildagliptin

Group Type OTHER

Vildagliptin

Intervention Type DRUG

Open α-GI add-on vildagliptin

Group Type OTHER

Vildagliptin

Intervention Type DRUG

Glinides add-on vildagliptin

Group Type OTHER

Vildagliptin

Intervention Type DRUG

Interventions

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Vildagliptin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmaceuticals Corporation

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Hunabashi, Chiba, Japan

Site Status

Novartis Investigative Site

Chikushino-shi, Fukuoka, Japan

Site Status

Novartis Investigative Site

Itoshima-shi, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kōriyama, Fukushima, Japan

Site Status

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Site Status

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Izumisano, Osaka, Japan

Site Status

Novartis Investigative Site

Hannou, Saitama, Japan

Site Status

Novartis Investigative Site

Hiki-Gun, Saitama, Japan

Site Status

Novartis Investigative Site

Kawaguchi, Saitama, Japan

Site Status

Novartis Investigative Site

Koshigaya, Saitama, Japan

Site Status

Novartis Investigative Site

Tokorozawa, Saitama, Japan

Site Status

Novartis Investigative Site

Edogawa-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Hachiōji, Tokyo, Japan

Site Status

Novartis Investigative Site

Katsushika-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Minato-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Shinagawa-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Toshima-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7543

Results for CLAF237A1308 from the Novartis Clinical Trials website

Other Identifiers

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CLAF237A1308

Identifier Type: -

Identifier Source: org_study_id

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