NCT01262586

Brief Summary

This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_3

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

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

December 16, 2010

Last Update Submit

November 16, 2016

Conditions

Type II Diabetes Mellitus

Keywords

Type II Diabetes MellitusVildagliptinGlimepirideContinuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • Change in Glycemic profiles between vildagliptin and glimepiride

    Baseline and treatment Day 5, 24hr continuous glucose measurements

Secondary Outcomes (1)

  • Glucose Fluctuation before and during treatment

    Baseline and treatment Day 5, 24hr continuous measurements

Study Arms (2)

Vildagliptin

EXPERIMENTAL
Drug: Vildagliptin

Glimepiride

ACTIVE COMPARATOR
Drug: Glimepiride

Interventions

VildagliptinDRUG
Vildagliptin
GlimepirideDRUG
Glimepiride

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes patients on stable metformin
  • years old
  • Willing to perform at least 4 capillary blood glucose tests per day

You may not qualify if:

  • Type 2 diabetes patients on any other antidiabetic treatment
  • Patients listed in other trials
  • Patients with significant diabetic organ disease or complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Mainz, Germany

Location

Related Publications (1)

  • He YL, Foteinos G, Neelakantham S, Mattapalli D, Kulmatycki K, Forst T, Taylor A. Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring. Diabetes Obes Metab. 2013 Dec;15(12):1111-9. doi: 10.1111/dom.12146. Epub 2013 Jul 14.

    PMID: 23782529RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptinglimepiride

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2010

First Posted

December 17, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

DE(1)