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Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

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ClinicalTrials.gov Identifier: NCT02138097
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : October 6, 2015
Last Update Posted : October 6, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
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.


Condition or disease
Diabetes Mellitus, Type 2

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Study Type : Observational
Actual Enrollment : 615067 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Description of Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns Including Initiation, Switching, and Discontinuation
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138097


Locations
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United States, Massachusetts
1218.161.1 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02138097    
Other Study ID Numbers: 1218.161
First Posted: May 14, 2014    Key Record Dates
Results First Posted: October 6, 2015
Last Update Posted: October 6, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases