NCT00389415

Brief Summary

This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
Last Updated

November 27, 2008

Status Verified

November 1, 2008

First QC Date

October 16, 2006

Last Update Submit

November 26, 2008

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 DiabetesVildagliptinHbA1c

Outcome Measures

Primary Outcomes (1)

  • Adverse events profile after 52 weeks of treatment

Secondary Outcomes (5)

  • Change from baseline to endpoint on HbA1c at 52 weeks

  • Change from baseline to endpoint on fasting plasma glucose at 52 weeks

  • Change from baseline to endpoint in HOMA B at 52 weeks

  • Change from baseline to endpoint in HOMA IR at 52 weeks

  • Change from baseline to endpoint in body weight at 52 weeks

Interventions

VildagliptinDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis as Type 2 Diabetes
  • Patients who have completed study CLAF237A1303
  • Outpatients

You may not qualify if:

  • Patients who prematurely discontinued Study CLAF237A1303

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Tokyo, Japan

Location

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 18, 2006

Study Start

October 1, 2006

Last Updated

November 27, 2008

Record last verified: 2008-11

Locations

JP(1)