Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

NCT ID: NCT01262586

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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

Detailed Description

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Conditions

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Type II Diabetes Mellitus

Keywords

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Type II Diabetes Mellitus Vildagliptin Glimepiride Continuous glucose monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vildagliptin

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Glimepiride

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

Interventions

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Vildagliptin

Intervention Type DRUG

Glimepiride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes patients on stable metformin
* 18-70 years old
* Willing to perform at least 4 capillary blood glucose tests per day

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Mainz, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 23782529 (View on PubMed)

Other Identifiers

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2010-021236-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLAF237A23151

Identifier Type: -

Identifier Source: org_study_id