Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138097
• Other study ID #: 1218.161
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: September 2, 2015
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615067
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
United States	1218.161.1 Boehringer Ingelheim Investigational Site	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Proportion of Days Covered for United Healthcare Patients	Number of days supply dispensed divided by number of days followed	up to 12 months	No
Secondary	Proportion of Days Covered for MarketScan Patients	Number of days supply dispensed divided by number of days followed	up to 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No