Vildagliptin Glycemic Profiles Assessment Using a Continu... | NCT01262586

Studies
Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

NCT01262586

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Nov 18, 2016Estimated

Enrollment

24Actual

Phase

Phase 3

Conditions

Type II Diabetes Mellitus

Interventions

Vildagliptin
Glimepiride

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-021236-34	EudraCT Number

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Dec 16, 2010

First Submission Date that Met QC Criteria

Dec 16, 2010

First Posted Date

Dec 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2016

Last Update Posted Date

Nov 18, 2016Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Label	Type	Description	Intervention Names
Vildagliptin	Experimental		Drug: Vildagliptin
Glimepiride	Active Comparator		Drug: Glimepiride

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin	Drug		Vildagliptin
Glimepiride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Glycemic profiles between vildagliptin and glimepiride		Baseline and treatment Day 5, 24hr continuous glucose measurements

Secondary Outcomes

Measure	Description	Time Frame
Glucose Fluctuation before and during treatment		Baseline and treatment Day 5, 24hr continuous measurements

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Mainz			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23782529	Result	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring