N/A
Completed N=615,067
Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns
Source: ClinicalTrials.gov NCT02138097 ↗Enrolled (actual)
615,067
Serious AEs
—
Results posted
Oct 2015
Primary outcomePrimary: Proportion of Initiators for United Healthcare Patients — 2.8; 0.5; 0.2; 69.9 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Initiators for United Healthcare Patients |
2.8; 0.5; 0.2; 69.9; 2.3; 5.8 | — |
| PRIMARY Proportion of Initiators for MarketScan Patients |
3.0; 0.4; 0.4; 69.1; 2.1; 5.9 | — |
| PRIMARY Treatment Switching for United Healthcare Patients |
117.76; 71.64; 122.97; 30.47; 57.38; 103.09 | — |
| PRIMARY Treatment Switching for MarketScan Patients |
110.35; 72.48; 96.88; 27.81; 60.31; 52.25 | — |
| PRIMARY Treatment Augmentation for United Healthcare Patients |
308.04; 274.68; 331.17; 204.43; 269.02; 340.69 | — |
| PRIMARY Treatment Augmentation for MarketScan Patients |
310.93; 309.36; 269.53; 201.04; 275.57; 237.31 | — |
| PRIMARY Subsequent Insulin Initiation for United Healthcare Patients |
112.61; 101.17; 162.97; 56.49; 97.37; 103.26 | — |
| PRIMARY Subsequent Insulin Initiation for MarketScan Patients |
109.1; 111.02; 168.83; 57.99; 105.7; 103.65 | — |
| SECONDARY Treatment Discontinuation for United Healthcare Patients |
523.32; 287.61; 466.55; 293.23; 267.60; 267.75 | — |
| SECONDARY Treatment Discontinuation for Marketscan Patients |
522.1; 284.67; 463.13; 285.58; 261.2; 262.24 | — |
| SECONDARY Proportion of Days Covered for United Healthcare Patients |
68.79; 77.54; 64.04; 70.37; 75.81; 73.09 | — |
| SECONDARY Proportion of Days Covered for MarketScan Patients |
72.04; 78.62; 69.58; 74.40; 78.13; 77.80 | — |
| SECONDARY Persistence at 3 Months for United Healthcare Patients |
68.90; 82.84; 59.12; 70.63; 81.40; 77.27 | — |
| SECONDARY Persistence at 6 Months for United Healthcare Patients |
42.02; 64.65; 34.29; 48.38; 62.90; 55.41 | — |
| SECONDARY Persistence at 12 Months for United Healthcare Patients |
28.35; 51.45; 22.64; 35.45; 49.75; 36.84 | — |
| SECONDARY Persistence at 3 Months for MarketScan Patients |
73.47; 83.39; 68.90; 76.89; 82.82; 81.58 | — |
| SECONDARY Persistence at 6 Months for MarketScan Patients |
42.70; 62.91; 39.32; 51.37; 63.07; 59.54 | — |
| SECONDARY Persistence at 12 Months for MarketScan Patients |
29.04; 50.30; 27.18; 39.32; 50.15; 46.83 | — |
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
Data sourced from ClinicalTrials.gov (NCT02138097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.