NCT00099853

Brief Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
362

participants targeted

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

Timeline
Completed

Started May 2004

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

December 17, 2020

Status Verified

January 1, 2013

Enrollment Period

3.7 years

First QC Date

December 21, 2004

Last Update Submit

December 11, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetesvildagliptin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c after 24 weeks

Secondary Outcomes (5)

  • Change from baseline in fasting plasma glucose at 24 weeks

  • Patients with endpoint HbA1c <7% after 24 weeks

  • Patients with reduction in HbA1c >/= to 0.7% after 24 weeks

  • Adverse event profile after 24 weeks of treatment

  • Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c

Study Arms (3)

Vildagliptin 50 mg qd + pioglitazone 45 mg qd

EXPERIMENTAL

Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks

Drug: VildagliptinDrug: pioglitazone

Vildagliptin 50 mg bid + pioglitazone 45 mg qd

EXPERIMENTAL

Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks

Drug: VildagliptinDrug: pioglitazone

Vildagliptin placebo + pioglitazone 45 mg qd

PLACEBO COMPARATOR

Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks

Drug: pioglitazoneDrug: Placebo

Interventions

VildagliptinDRUG

Vildagliptin 50 mg tablets

Also known as: LAF237, Galvus
Vildagliptin 50 mg bid + pioglitazone 45 mg qdVildagliptin 50 mg qd + pioglitazone 45 mg qd
pioglitazoneDRUG

pioglitazone 45 mg qd

Vildagliptin 50 mg bid + pioglitazone 45 mg qdVildagliptin 50 mg qd + pioglitazone 45 mg qdVildagliptin placebo + pioglitazone 45 mg qd
PlaceboDRUG

Vildagliptin matching placebo

Vildagliptin placebo + pioglitazone 45 mg qd

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood glucose criteria must be met
  • Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
  • Body mass index (BMI) in the range 22-45

You may not qualify if:

  • Type 1 diabetes
  • Pregnancy or lactation
  • Evidence of serious cardiovascular complications
  • Evidence of serious diabetic complications
  • Laboratory value abnormalities as defined by the protocol
  • Known sensitivity to pioglitazone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74. doi: 10.1111/j.1463-1326.2006.00684.x.

    PMID: 17300592DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidinePioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolidinedionesThiazolesSulfur CompoundsAzoles

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 21, 2004

First Posted

December 22, 2004

Study Start

May 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 17, 2020

Record last verified: 2013-01

Locations

US(1)