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

December 11, 2020 updated by: Novartis Pharmaceuticals

A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 807-0857
        • Novartis Investigative Site
      • Fukuoka, Japan, 816-0094
        • Novartis Investigative Site
      • Fukuoka, Japan, 819-0168
        • Novartis Investigative Site
    • Chiba
      • Hunabashi, Chiba, Japan, 274-0805
        • Novartis Investigative Site
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-0036
        • Novartis Investigative Site
      • Itoshima-shi, Fukuoka, Japan, 819-1102
        • Novartis Investigative Site
    • Fukushima
      • Koriyama, Fukushima, Japan, 963-8851
        • Novartis Investigative Site
    • Hyogo
      • Kobe, Hyogo, Japan, 658-0064
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 210-0852
        • Novartis Investigative Site
      • Kawasaki, Kanagawa, Japan, 212-0024
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 221-0065
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 221-0077
        • Novartis Investigative Site
    • Osaka
      • Izumisano, Osaka, Japan, 598-0048
        • Novartis Investigative Site
    • Saitama
      • 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
    • Tokyo
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure AEs, vital signs, laboratory evaluations
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HBA1c
Time Frame: 52 weeks
52 weeks
Fasting Plasma Glucose
Time Frame: 52 weeks
52 weeks
Fasting Insulin
Time Frame: 52 weeks
52 weeks
Fasting C-peptide
Time Frame: 52 weeks
52 weeks
HOMA-B
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 9, 2010

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A1308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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