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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Vildagliptin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Open Met add-on vildagliptin

Open TZD add-on vildagliptin

Open α-GI add-on vildagliptin

Glinides add-on vildagliptin

Arm Description

Outcomes

Primary Outcome Measures

Measure AEs, vital signs, laboratory evaluations

Secondary Outcome Measures

HBA1c
Fasting Plasma Glucose
Fasting Insulin
Fasting C-peptide
HOMA-B

Full Information

First Posted
July 7, 2010
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01159249
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Met add-on vildagliptin
Arm Type
Other
Arm Title
Open TZD add-on vildagliptin
Arm Type
Other
Arm Title
Open α-GI add-on vildagliptin
Arm Type
Other
Arm Title
Glinides add-on vildagliptin
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Primary Outcome Measure Information:
Title
Measure AEs, vital signs, laboratory evaluations
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
HBA1c
Time Frame
52 weeks
Title
Fasting Plasma Glucose
Time Frame
52 weeks
Title
Fasting Insulin
Time Frame
52 weeks
Title
Fasting C-peptide
Time Frame
52 weeks
Title
HOMA-B
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals Corporation
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Hunabashi
State/Province
Chiba
ZIP/Postal Code
274-0805
Country
Japan
Facility Name
Novartis Investigative Site
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-0036
Country
Japan
Facility Name
Novartis Investigative Site
City
Itoshima-shi
State/Province
Fukuoka
ZIP/Postal Code
819-1102
Country
Japan
Facility Name
Novartis Investigative Site
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8851
Country
Japan
Facility Name
Novartis Investigative Site
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
658-0064
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
212-0024
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
221-0077
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
221-0065
Country
Japan
Facility Name
Novartis Investigative Site
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Novartis Investigative Site
City
Hannou
State/Province
Saitama
ZIP/Postal Code
357-0024
Country
Japan
Facility Name
Novartis Investigative Site
City
Hiki-Gun
State/Province
Saitama
ZIP/Postal Code
355-0328
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawaguchi
State/Province
Saitama
ZIP/Postal Code
332-0012
Country
Japan
Facility Name
Novartis Investigative Site
City
Koshigaya city
State/Province
Saitama
ZIP/Postal Code
343-0826
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1161
Country
Japan
Facility Name
Novartis Investigative Site
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
134-0084
Country
Japan
Facility Name
Novartis Investigative Site
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
Facility Name
Novartis Investigative Site
City
Katsushika-ku
State/Province
Tokyo
ZIP/Postal Code
125-0041
Country
Japan
Facility Name
Novartis Investigative Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0032
Country
Japan
Facility Name
Novartis Investigative Site
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
807-0857
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
816-0094
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
819-0168
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7543
Description
Results for CLAF237A1308 from the Novartis Clinical Trials website

Learn more about this trial

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

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