Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT02138097
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-14
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Results First Submitted: 2015-07-29
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-02
• Last Update Submitted: 2015-09-02
• Results First Posted: 2015-10-06
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615067

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Augmentation for MarketScan Patients	up to 12 months	Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy
Subsequent Insulin Initiation for United Healthcare Patients	up to 12 months	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
Treatment Switching for United Healthcare Patients	up to 12 months	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
Treatment Switching for MarketScan Patients	up to 12 months	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
Treatment Augmentation for United Healthcare Patients	up to 12 months	Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy
Subsequent Insulin Initiation for MarketScan Patients	up to 12 months	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
Proportion of Initiators for United Healthcare Patients	up to 12 months	Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.
Proportion of Initiators for MarketScan Patients	up to 12 months	Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.

Secondary Outcome Measures

Name	Time	Method
Treatment Discontinuation for United Healthcare Patients	up to 12 months	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)
Persistence at 6 Months for United Healthcare Patients	6 months	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.
Proportion of Days Covered for United Healthcare Patients	up to 12 months	Number of days supply dispensed divided by number of days followed
Persistence at 3 Months for United Healthcare Patients	3 months	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.
Persistence at 3 Months for MarketScan Patients	3 months	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.
Treatment Discontinuation for Marketscan Patients	up to 12 months	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)
Proportion of Days Covered for MarketScan Patients	up to 12 months	Number of days supply dispensed divided by number of days followed
Persistence at 12 Months for United Healthcare Patients	12 months	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.
Persistence at 12 Months for MarketScan Patients	12 months	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.
Persistence at 6 Months for MarketScan Patients	6 months	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.

Trial Locations

Locations (1)

1218.161.1 Boehringer Ingelheim Investigational Site; 🇺🇸 Boston, Massachusetts, United States