Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

Boehringer Ingelheim615,067 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

615,067

Conditions

Diabetes Mellitus, Type 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Proportion of Initiators for United Healthcare Patients

Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.

Time frame: up to 12 months

Proportion of Initiators for MarketScan Patients

Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.

Time frame: up to 12 months

Treatment Switching for United Healthcare Patients

Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days

Time frame: up to 12 months

Treatment Switching for MarketScan Patients

Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days

Time frame: up to 12 months

Treatment Augmentation for United Healthcare Patients

Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy

Time frame: up to 12 months

Treatment Augmentation for MarketScan Patients

Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy

Time frame: up to 12 months

Subsequent Insulin Initiation for United Healthcare Patients

Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months

Time frame: up to 12 months

Subsequent Insulin Initiation for MarketScan Patients

Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months

Time frame: up to 12 months

Secondary Outcomes

Treatment Discontinuation for United Healthcare Patients

Number of patients with a treatment gap of \>=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)

Time frame: up to 12 months

Treatment Discontinuation for Marketscan Patients

Number of patients with a treatment gap of \>=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)

Time frame: up to 12 months

Proportion of Days Covered for United Healthcare Patients

Number of days supply dispensed divided by number of days followed

Time frame: up to 12 months

Proportion of Days Covered for MarketScan Patients

Number of days supply dispensed divided by number of days followed

Time frame: up to 12 months

Persistence at 3 Months for United Healthcare Patients

Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.

Time frame: 3 months

Persistence at 6 Months for United Healthcare Patients

Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.

Time frame: 6 months

Persistence at 12 Months for United Healthcare Patients

Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.

Time frame: 12 months