NCT01159249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 17, 2020

Status Verified

May 1, 2012

Enrollment Period

1.6 years

First QC Date

July 7, 2010

Last Update Submit

December 11, 2020

Conditions

Type 2 Diabetes

Keywords

Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety

Outcome Measures

Primary Outcomes (1)

  • Measure AEs, vital signs, laboratory evaluations

    52 weeks

Secondary Outcomes (5)

  • HBA1c

    52 weeks

  • Fasting Plasma Glucose

    52 weeks

  • Fasting Insulin

    52 weeks

  • Fasting C-peptide

    52 weeks

  • HOMA-B

    52 weeks

Study Arms (4)

Open Met add-on vildagliptin

OTHER
Drug: Vildagliptin

Open TZD add-on vildagliptin

OTHER
Drug: Vildagliptin

Open α-GI add-on vildagliptin

OTHER
Drug: Vildagliptin

Glinides add-on vildagliptin

OTHER
Drug: Vildagliptin

Interventions

VildagliptinDRUG
Glinides add-on vildagliptinOpen Met add-on vildagliptinOpen TZD add-on vildagliptinOpen α-GI add-on vildagliptin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases
  • Significant diabetic complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Novartis Investigative Site

Hunabashi, Chiba, 274-0805, Japan

Location

Novartis Investigative Site

Chikushino-shi, Fukuoka, 818-0036, Japan

Location

Novartis Investigative Site

Itoshima-shi, Fukuoka, 819-1102, Japan

Location

Novartis Investigative Site

Kōriyama, Fukushima, 963-8851, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 658-0064, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 210-0852, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 212-0024, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 221-0065, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 221-0077, Japan

Location

Novartis Investigative Site

Izumisano, Osaka, 598-0048, Japan

Location

Novartis Investigative Site

Hannou, Saitama, 357-0024, Japan

Location

Novartis Investigative Site

Hiki-Gun, Saitama, 355-0328, Japan

Location

Novartis Investigative Site

Kawaguchi, Saitama, 332-0012, Japan

Location

Novartis Investigative Site

Koshigaya, Saitama, 343-0826, Japan

Location

Novartis Investigative Site

Tokorozawa, Saitama, 359-1161, Japan

Location

Novartis Investigative Site

Edogawa-ku, Tokyo, 134-0084, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0046, Japan

Location

Novartis Investigative Site

Katsushika-ku, Tokyo, 125-0041, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 141-0032, Japan

Location

Novartis Investigative Site

Toshima-ku, Tokyo, 171-0021, Japan

Location

Novartis Investigative Site

Fukuoka, 807-0857, Japan

Location

Novartis Investigative Site

Fukuoka, 816-0094, Japan

Location

Novartis Investigative Site

Fukuoka, 819-0168, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Novartis Pharmaceuticals Corporation

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 9, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 17, 2020

Record last verified: 2012-05

Locations

JP(24)