Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

Study Overview
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Brief Summary
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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.

Official Title
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A Description of Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns Including Initiation, Switching, and Discontinuation

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glitazones<br> | |
| Linagliptin<br> | |
| Meglitinides<br> | |
| Metformin<br> | |
| Non-insulin injectables<br> | |
| Saxagliptin<br> | |
| Sitagliptin<br> | |
| Sulfonylurea<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | up to 12 months | 
| Proportion of Days Covered for United Healthcare Patients | Number of days supply dispensed divided by number of days followed | up to 12 months | 
| Proportion of Days Covered for MarketScan Patients | Number of days supply dispensed divided by number of days followed | 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. | 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. | 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. | 12 months | 
| Persistence at 3 Months for MarketScan 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. | 3 months | 
| Persistence at 6 Months for MarketScan 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. | 6 months | 
| Persistence at 12 Months for MarketScan 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. | 12 months |