Prescription Patterns, Resource Utilization & Costs - Add... | NCT01332370

Studies
Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone

NCT01332370

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jun 2, 2017Actual

Enrollment

5,391Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

Rosiglitazone + Metformin
Sitagliptin + Metformin

Countries

Not provided

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

Status Module

Record Verification Date

Jun 2011

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

Dec 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Apr 7, 2011

First Submission Date that Met QC Criteria

Apr 7, 2011

First Posted Date

Apr 11, 2011Estimated

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

Jun 1, 2017

Last Update Posted Date

Jun 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This retrospective database study analyzed resource utilization and costs associated with sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a large US healthcare plan.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,391Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults with Type 2 Diabetes		Subjects with a diagnosis (ICD-9 code) of diabetes	Drug: Rosiglitazone + Metformin Drug: Sitagliptin + Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rosiglitazone + Metformin	Drug	At least 180 days of continuous therapy with RSG+MET after the first Rx for RSG	Adults with Type 2 Diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
medical resource utilization	Direct healthcare and indirect sick leave costs	at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Continuously enrolled in the health insurance plan to ensure complete claims coverage
At least 1 claim with a diagnosis of diabetes (ICD-9 250.xx)
Aged 18 years or older at the index date
At least 6 months of baseline period prior to the index date
At least 1 claim for MET during the baseline period
At least 180 days of continuous therapy with RSG+MET or STG+MET after the index date

Exclusion Criteria:

At least 1 claim for insulin or sulfonylurea in the baseline period
At least 1 claim with a diagnosis of congestive heart failure in the baseline period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Adults continuously enrolled in a large US health insurance plan with a diagnosis of diabetes who are currently receiving Metformin

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C471074	rosiglitazone-metformin combination
D000068900	Sitagliptin Phosphate
D008687	Metformin

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided