Clinical trial NCT02138097: Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns
Official title: A Description of Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns Including Initiation, Switching, and Discontinuation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-05-14
Enrollment: 615067
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T2DM patients aged 18 years or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment

Brief summary: This protocol is for a series of descriptive analyses conducted within a cohort of patients using linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, and other oral and non-insulin injected hypoglycemic medications between May 2011 and July 2012.

Understanding 1) the existing utilization patterns for linagliptin, sitagliptin, saxagliptin, and other oral and non-insulin injected hypoglycemic agents and (2) the differences in utilization patterns between these agents will help with the design, analysis and interpretation of comparative effectiveness and safety studies of linagliptin, other DPP-4 inhibitors, and other agents.

The study will provide an overview of existing utilization patterns for linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, other oral and non-insulin injected hypoglycemic agents, in order to detect potential selective prescribing patterns that might lead to channeling bias.


Eligibility criteria: Inclusion criteria:

* diagnosis of type 2 diabetes mellitus
* a dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012
* at least 6 months enrolment in the database preceding the date of the first dispensing

Exclusion criteria:

* age \< 18
* missing or ambiguous age or sex information
* at least one diagnosis of type 1 diabetes mellitus or secondary diabetes

Primary outcomes:
measure: Proportion of Initiators for United Healthcare Patients
timeFrame: up to 12 months
measure: Proportion of Initiators for MarketScan Patients
timeFrame: up to 12 months
measure: Treatment Switching for United Healthcare Patients
timeFrame: up to 12 months
measure: Treatment Switching for MarketScan Patients
timeFrame: up to 12 months
measure: Treatment Augmentation for United Healthcare Patients
timeFrame: up to 12 months
measure: Treatment Augmentation for MarketScan Patients
timeFrame: up to 12 months
measure: Subsequent Insulin Initiation for United Healthcare Patients
timeFrame: up to 12 months
measure: Subsequent Insulin Initiation for MarketScan Patients
timeFrame: up to 12 months
Secondary outcomes:
measure: Treatment Discontinuation for United Healthcare Patients
timeFrame: up to 12 months
measure: Treatment Discontinuation for Marketscan Patients
timeFrame: up to 12 months
measure: Proportion of Days Covered for United Healthcare Patients
timeFrame: up to 12 months
measure: Proportion of Days Covered for MarketScan Patients
timeFrame: up to 12 months
measure: Persistence at 3 Months for United Healthcare Patients
timeFrame: 3 months
measure: Persistence at 6 Months for United Healthcare Patients
timeFrame: 6 months
measure: Persistence at 12 Months for United Healthcare Patients
timeFrame: 12 months
measure: Persistence at 3 Months for MarketScan Patients
timeFrame: 3 months
measure: Persistence at 6 Months for MarketScan Patients
timeFrame: 6 months
measure: Persistence at 12 Months for MarketScan Patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: 1218.161.1 Boehringer Ingelheim Investigational Site
state: Massachusetts
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: