NCT00383578

Brief Summary

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

Trial Health

85
On Track

Trial Health Score

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

Enrollment
335

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Last Updated

December 17, 2020

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

September 29, 2006

Last Update Submit

December 11, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesvildagliptinhemoglobin A1cmetformin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c

    after 24 weeks of treatment

Secondary Outcomes (5)

  • Adverse event profile

    after 24 weeks of treatment

  • Gastrointestinal tolerability

    after 24 weeks of treatment

  • Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%

    after 24 weeks of treatment

  • Change from baseline in fasting plasma glucose

    after 24 weeks of treatment

  • Change from baseline in body weight

    after 24 weeks of treatment

Study Arms (2)

Vildagliptin

EXPERIMENTAL
Drug: Vildagliptin 100 mg qd

Metformin

ACTIVE COMPARATOR
Drug: Metformin 1500 mg daily

Interventions

Vildagliptin 100 mg qdDRUG
Vildagliptin
Metformin 1500 mg dailyDRUG
Metformin

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age from 65 years to the upper age limit recommended by local prescribing information for metformin
  • Drug naive patients with type 2 diabetes.
  • Body mass index (BMI) in the range of 22-40 kg/m2.
  • HbA1c in the range of 7 to 9% inclusive
  • FPG \<270 mg/dL (15 mmol/L)

You may not qualify if:

  • A history of type 1 diabetes
  • Evidence of significant diabetic complications
  • Treatment with insulin or any other oral antidiabetic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigative Centers

Nuremberg, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 3, 2006

Study Start

September 1, 2006

Primary Completion

May 1, 2008

Last Updated

December 17, 2020

Record last verified: 2013-01

Locations

CH(1)DE(1)