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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

Tracking Information
First Submitted Date May 13, 2014
First Posted Date May 14, 2014
Results First Submitted Date July 29, 2015
Results First Posted Date October 6, 2015
Last Update Posted Date October 6, 2015
Study Start Date May 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2015)
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: May 13, 2014)
  • Proportion of initiators: Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent [ Time Frame: up to 12 months ]
  • Treatment switching: Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent + 30 days [ Time Frame: up to 12 months ]
  • Treatment augmentation: Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy [ Time Frame: up to 12 months ]
  • Subsequent Insulin initiation: 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 [ Time Frame: up to 12 months ]
Change History
Current Secondary Outcome Measures
 (submitted: September 2, 2015)
  • 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)
  • 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)
  • 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
  • Proportion of Days Covered for MarketScan Patients [ Time Frame: up to 12 months ]
    Number of days supply dispensed divided by number of days followed
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: May 13, 2014)
  • Proportion of Days Covered: Number of days supply dispensed divided by number of days followed [ Time Frame: up to 12 months ]
  • Persistence at 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. [ Time Frame: 3 months ]
  • Persistence at 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. [ Time Frame: 6 months ]
  • Persistence at 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. [ Time Frame: 12 months ]
  • Treatment discontinuation: 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) [ Time Frame: up to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns
Official Title A Description of Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns Including Initiation, Switching, and Discontinuation
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Diabetes Mellitus, Type 2
Intervention Not Provided
Study Groups/Cohorts
  • Glitazones
  • Linagliptin
  • Meglitinides
  • Metformin
  • Non-insulin injectables
  • Saxagliptin
  • Sitagliptin
  • Sulfonylurea
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 2, 2015)
615067
Original Estimated Enrollment
 (submitted: May 13, 2014)
200000
Actual Study Completion Date August 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02138097
Other Study ID Numbers 1218.161
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date September 2015