Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2

• Study Type: Observational
• Enrollment (Actual): 615067

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States
      • 1218.161.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
Glitazones
Linagliptin
Meglitinides
Metformin
Non-insulin injectables
Saxagliptin
Sitagliptin
Sulfonylurea

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1218.161