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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glitazones | |||
| Linagliptin | |||
| Meglitinides | |||
| Metformin | |||
| Non-insulin injectables | |||
| Saxagliptin | |||
| Sitagliptin | |||
| Sulfonylurea |
Not provided
| 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 |
| 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
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T2DM patients aged 18 years or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.161.1 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States |
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Existing data cohort design using data from the United Healthcare and MarketScan databases from May 2011 through July 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | United Healthcare | Patients using an oral and non-insulin injected glucose-lowering medication identified from the United Healthcare Research database |
| FG001 | MarketScan | Patients using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients included in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | UHC: Glitazones | Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication. |
| BG001 | UHC: Linagliptin | Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects in the United Healthcare cohort | Posted | Number | Percentage of participants | up to 12 months |
|
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Serious and other (non-serious) adverse events were not of interest in this study and therefore were not collected or assessed as part of the study, in addition individual patient data is not available therefore adverse event data is not presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glitazones | Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
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 |
| BG002 | UHC: Meglitinides | Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication. |
| BG003 | UHC: Metformin | Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication. |
| BG004 | UHC: Saxagliptin | Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. |
| BG005 | UHC: Sitagliptin | Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. |
| BG006 | UHC: Sulfonylurea | Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. |
| BG007 | UHC: Alpha-Glucosidase Inhibitors | Patients in the United Healthcare cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication. |
| BG008 | UHC: GLP-I RA | Patients in the United Healthcare cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication. |
| BG009 | MS: Linagliptin | Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication. |
| BG010 | MS: Sitagliptin | Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. |
| BG011 | MS: Saxagliptin | Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. |
| BG012 | MS: Metformin | Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication. |
| BG013 | MS: Sulfonylurea | Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. |
| BG014 | MS: Glitazones | Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication. |
| BG015 | MS: Meglitinides | Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication. |
| BG016 | MS: Alpha-Glucosidase Inhibitors | Patients in the MarketScan (MS) cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication. |
| BG017 | MS: GLP-I RA | Patients in the MarketScan (MS) cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication. |
| BG018 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Meglitinides |
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication. |
| OG003 | Metformin | Patients using Metformin as an oral and non-insulin injected glucose-lowering medication. |
| OG004 | Saxagliptin | Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. |
| OG005 | Sitagliptin | Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. |
| OG006 | Sulfonylurea | Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. |
| OG007 | Alpha-Glucosidase Inhibitors | Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication. |
| OG008 | GLP-I RA | Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication. |
|
|
| Primary | 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. | All subjects in MarketScan cohort | Posted | Number | Percentage of participants | up to 12 months |
|
|
|
| Primary | 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 | All subjects in United Healthcare cohort | Posted | Number | participants/1000 participant years | up to 12 months |
|
|
|
| Primary | 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 | All subjects in MarketScan cohort | Posted | Number | participants/1000 participant years | up to 12 months |
|
|
|
| Primary | 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 | All patients in United Healthcare cohort | Posted | Number | participants/1000 participant years | up to 12 months |
|
|
|
| Primary | 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 | All patients in MarketScan cohort | Posted | Number | participants/1000 participant years | up to 12 months |
|
|
|
| Primary | 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 | All patients in United Healthcare cohort | Posted | Number | participants/1000 participant years | up to 12 months |
|
|
|
| Primary | 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 | All patients in MarketScan cohort | Posted | Number | participants/1000 participant years | up to 12 months |
|
|
|
| Secondary | 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) | All subjects in United Healthcare cohort | Posted | Number | participants/1000 participant years | up to 12 months |
|
|
|
| Secondary | 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) | All subjects in Marketscan cohort | Posted | Number | participants/1000 participant years | up to 12 months |
|
|
|
| Secondary | Proportion of Days Covered for United Healthcare Patients | Number of days supply dispensed divided by number of days followed | All patients in United Healthcare cohort | Posted | Mean | Standard Deviation | days covered | up to 12 months |
|
|
|
| Secondary | Proportion of Days Covered for MarketScan Patients | Number of days supply dispensed divided by number of days followed | All patients in MarketScan cohort | Posted | Mean | Standard Deviation | days covered | up to 12 months |
|
|
|
| Secondary | 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. | All patients in United Healthcare cohort | Posted | Number | Percentage of participants | 3 months |
|
|
|
| Secondary | 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. | All patients in United Healthcare cohort | Posted | Number | Percentage of participants | 6 months |
|
|
|
| Secondary | 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. | All patients in United Healthcare cohort | Posted | Number | Percentage of participants | 12 months |
|
|
|
| Secondary | 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. | All patients in MarketScan cohort | Posted | Number | Percentage of participants | 3 months |
|
|
|
| Secondary | 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. | All patients in MarketScan cohort | Posted | Number | Percentage of participants | 6 months |
|
|
|
| Secondary | 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. | All patients in MarketScan cohort | Posted | Number | Percentage of participants | 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Linagliptin | Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
| EG002 | Meglitinides | Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
| EG003 | Metformin | Patients using Metformin as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
| EG004 | Saxagliptin | Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
| EG005 | Sitagliptin | Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
| EG006 | Sulfonylurea | Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
| EG007 | Other DPP-4I | Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
| EG008 | Alpha-Glucosidase Inhibitors | Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
| EG009 | GLP-I RA | Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication. | 0 | 0 | 0 | 0 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D004700 | Endocrine System Diseases |
| Non-naive new users |
|
| Monotherapy |
|
| Dual Therapy |
|
| Other initiation other than mono- or dual therapy |
|