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Completed

NCT Number: NCT02138097

Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1218.161.1 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of Initiators for United Healthcare Patients

    Time frame: 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.

  2. Proportion of Initiators for MarketScan Patients

    Time frame: 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.

  3. Treatment Switching for United Healthcare Patients

    Time frame: 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

  4. Treatment Switching for MarketScan Patients

    Time frame: 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

  5. Treatment Augmentation for United Healthcare Patients

    Time frame: up to 12 months

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

  6. Treatment Augmentation for MarketScan Patients

    Time frame: up to 12 months

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

  7. Subsequent Insulin Initiation for United Healthcare Patients

    Time frame: 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

  8. Subsequent Insulin Initiation for MarketScan Patients

    Time frame: 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

Secondary outcomes

  1. Treatment Discontinuation for United Healthcare Patients

    Time frame: 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)

  2. Treatment Discontinuation for Marketscan Patients

    Time frame: 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)

  3. Proportion of Days Covered for United Healthcare Patients

    Time frame: up to 12 months

    Number of days supply dispensed divided by number of days followed

  4. Proportion of Days Covered for MarketScan Patients

    Time frame: up to 12 months

    Number of days supply dispensed divided by number of days followed

  5. Persistence at 3 Months for United Healthcare Patients

    Time frame: 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.

  6. Persistence at 6 Months for United Healthcare Patients

    Time frame: 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.

  7. Persistence at 12 Months for United Healthcare Patients

    Time frame: 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.

  8. Persistence at 3 Months for MarketScan Patients

    Time frame: 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.

  9. Persistence at 6 Months for MarketScan Patients

    Time frame: 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.

  10. Persistence at 12 Months for MarketScan Patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 14, 2014
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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