NCT00351884

Brief Summary

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
370

participants targeted

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

Geographic Reach
2 countries

2 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

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

July 11, 2006

Last Update Submit

November 16, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesvildagliptinHemoglobin A1c

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at 24 weeks

    24 weeks

Secondary Outcomes (5)

  • Safety of vildagliptin in combination with metformin during 24 weeks of treatment

    24 weeks

  • Change from baseline in fasting plasma glucose at 24 weeks

    24 weeks

  • Patients with endpoint HbA1c < 7% after 24 weeks

    24 weeks

  • Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks

    24 weeks

  • Change from baseline in body weight at 24 weeks

    24 weeks

Study Arms (3)

vildagliptin am

EXPERIMENTAL
Drug: Vildagliptin AM

vildagliptin pm

EXPERIMENTAL
Drug: vildagliptin pm

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

Vildagliptin AMDRUG
vildagliptin am
vildagliptin pmDRUG
vildagliptin pm
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
  • Body mass index in the range 22-40
  • Blood glucose criteria must be met

You may not qualify if:

  • Pregnancy or lactation
  • History of type 1 diabetes
  • Evidence of significant diabetic complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Novartis Investigative Site

Investigative Centers, Germany

Location

Related Publications (1)

  • Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16.

    PMID: 19221978RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

May 1, 2006

Primary Completion

November 1, 2007

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

US(1)DE(1)