Diabetes Mellitus, Type 2
Conditions
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.
Interventions
None listed
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Initiators for United Healthcare Patients | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Persistence at 6 Months for MarketScan Patients | 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. |
| Treatment Discontinuation for United Healthcare Patients | 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) |
| Persistence at 12 Months for MarketScan Patients | 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. |
| Treatment Discontinuation for Marketscan Patients | 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 | up to 12 months | Number of days supply dispensed divided by number of days followed |
| Proportion of Days Covered for MarketScan Patients | up to 12 months | Number of days supply dispensed divided by number of days followed |
| Persistence at 3 Months for United Healthcare Patients | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Existing data cohort design using data from the United Healthcare and MarketScan databases from May 2011 through July 2012
Participants by arm
| Arm | Count |
|---|---|
| UHC: Glitazones Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication. | 7,203 |
| UHC: Linagliptin Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication. | 2,820 |
| UHC: Meglitinides Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication. | 1,184 |
| UHC: Metformin Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication. | 72,694 |
| UHC: Saxagliptin Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. | 8,100 |
| UHC: Sitagliptin Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. | 18,491 |
| UHC: Sulfonylurea Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. | 33,868 |
| 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. | 495 |
| 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. | 10,490 |
| MS: Linagliptin Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication. | 7,708 |
| MS: Sitagliptin Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. | 58,769 |
| MS: Saxagliptin Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. | 24,550 |
| MS: Metformin Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication. | 205,213 |
| MS: Sulfonylurea Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. | 104,422 |
| MS: Glitazones Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication. | 22,310 |
| MS: Meglitinides Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication. | 5,412 |
| 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. | 1,918 |
| 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. | 29,420 |
| Total | 615,067 |
Baseline characteristics
| Characteristic | Total | UHC: Linagliptin | UHC: Meglitinides | UHC: Metformin | UHC: Saxagliptin | UHC: Sitagliptin | UHC: Sulfonylurea | UHC: Alpha-Glucosidase Inhibitors | UHC: GLP-I RA | MS: Linagliptin | MS: Sitagliptin | MS: Saxagliptin | MS: Metformin | MS: Sulfonylurea | MS: Glitazones | MS: Meglitinides | MS: Alpha-Glucosidase Inhibitors | UHC: Glitazones | MS: GLP-I RA |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 55.05 years STANDARD_DEVIATION 11.22 | 55.90 years STANDARD_DEVIATION 10.06 | 57.08 years STANDARD_DEVIATION 10.46 | 52.57 years STANDARD_DEVIATION 10.56 | 53.68 years STANDARD_DEVIATION 9.66 | 54.40 years STANDARD_DEVIATION 10.16 | 53.75 years STANDARD_DEVIATION 10.4 | 55.93 years STANDARD_DEVIATION 10.67 | 52.35 years STANDARD_DEVIATION 9.54 | 58.72 years STANDARD_DEVIATION 11.66 | 58.42 years STANDARD_DEVIATION 11.98 | 56.84 years STANDARD_DEVIATION 11.39 | 55.91 years STANDARD_DEVIATION 12.08 | 57.94 years STANDARD_DEVIATION 12.49 | 57.40 years STANDARD_DEVIATION 11.66 | 62.50 years STANDARD_DEVIATION 12.6 | 59.96 years STANDARD_DEVIATION 12 | 53.67 years STANDARD_DEVIATION 9.99 | 54.28 years STANDARD_DEVIATION 10.02 |
| Sex: Female, Male Female | 278793 Participants | 1175 Participants | 505 Participants | 32251 Participants | 3400 Participants | 7600 Participants | 13631 Participants | 201 Participants | 5521 Participants | 3368 Participants | 26158 Participants | 10838 Participants | 97105 Participants | 45668 Participants | 9181 Participants | 2526 Participants | 909 Participants | 2679 Participants | 16077 Participants |
| Sex: Female, Male Male | 336274 Participants | 1645 Participants | 679 Participants | 40443 Participants | 4700 Participants | 10891 Participants | 20237 Participants | 294 Participants | 4969 Participants | 4340 Participants | 32611 Participants | 13712 Participants | 108108 Participants | 58754 Participants | 13129 Participants | 2886 Participants | 1009 Participants | 4524 Participants | 13343 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: up to 12 months
Population: All subjects in MarketScan cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glitazones | Proportion of Initiators for MarketScan Patients | Non-naive new users | 6.5 Percentage of participants |
| Glitazones | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 9.6 Percentage of participants |
| Glitazones | Proportion of Initiators for MarketScan Patients | Naive new users | 3.0 Percentage of participants |
| Glitazones | Proportion of Initiators for MarketScan Patients | Dual Therapy | 5.1 Percentage of participants |
| Glitazones | Proportion of Initiators for MarketScan Patients | Monotherapy | 2.5 Percentage of participants |
| Linagliptin | Proportion of Initiators for MarketScan Patients | Monotherapy | 1.0 Percentage of participants |
| Linagliptin | Proportion of Initiators for MarketScan Patients | Naive new users | 0.4 Percentage of participants |
| Linagliptin | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 3.0 Percentage of participants |
| Linagliptin | Proportion of Initiators for MarketScan Patients | Non-naive new users | 2.8 Percentage of participants |
| Linagliptin | Proportion of Initiators for MarketScan Patients | Dual Therapy | 1.7 Percentage of participants |
| Meglitinides | Proportion of Initiators for MarketScan Patients | Dual Therapy | 1.0 Percentage of participants |
| Meglitinides | Proportion of Initiators for MarketScan Patients | Monotherapy | 0.6 Percentage of participants |
| Meglitinides | Proportion of Initiators for MarketScan Patients | Naive new users | 0.4 Percentage of participants |
| Meglitinides | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 2.7 Percentage of participants |
| Meglitinides | Proportion of Initiators for MarketScan Patients | Non-naive new users | 1.9 Percentage of participants |
| Metformin | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 16.9 Percentage of participants |
| Metformin | Proportion of Initiators for MarketScan Patients | Non-naive new users | 23.2 Percentage of participants |
| Metformin | Proportion of Initiators for MarketScan Patients | Dual Therapy | 34.0 Percentage of participants |
| Metformin | Proportion of Initiators for MarketScan Patients | Naive new users | 69.1 Percentage of participants |
| Metformin | Proportion of Initiators for MarketScan Patients | Monotherapy | 66.1 Percentage of participants |
| Saxagliptin | Proportion of Initiators for MarketScan Patients | Monotherapy | 2.6 Percentage of participants |
| Saxagliptin | Proportion of Initiators for MarketScan Patients | Naive new users | 2.1 Percentage of participants |
| Saxagliptin | Proportion of Initiators for MarketScan Patients | Non-naive new users | 8.1 Percentage of participants |
| Saxagliptin | Proportion of Initiators for MarketScan Patients | Dual Therapy | 6.6 Percentage of participants |
| Saxagliptin | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 9.0 Percentage of participants |
| Sitagliptin | Proportion of Initiators for MarketScan Patients | Non-naive new users | 18.8 Percentage of participants |
| Sitagliptin | Proportion of Initiators for MarketScan Patients | Monotherapy | 6.3 Percentage of participants |
| Sitagliptin | Proportion of Initiators for MarketScan Patients | Dual Therapy | 15.6 Percentage of participants |
| Sitagliptin | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 21.8 Percentage of participants |
| Sitagliptin | Proportion of Initiators for MarketScan Patients | Naive new users | 5.9 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for MarketScan Patients | Monotherapy | 17.4 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for MarketScan Patients | Non-naive new users | 27.5 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for MarketScan Patients | Naive new users | 17.2 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for MarketScan Patients | Dual Therapy | 29.7 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 21.4 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for MarketScan Patients | Monotherapy | 0.2 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for MarketScan Patients | Non-naive new users | 0.7 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 1.1 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for MarketScan Patients | Dual Therapy | 0.3 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for MarketScan Patients | Naive new users | 0.1 Percentage of participants |
| GLP-I RA | Proportion of Initiators for MarketScan Patients | Other initiation other than mono- or dual therapy | 14.5 Percentage of participants |
| GLP-I RA | Proportion of Initiators for MarketScan Patients | Naive new users | 1.6 Percentage of participants |
| GLP-I RA | Proportion of Initiators for MarketScan Patients | Dual Therapy | 5.8 Percentage of participants |
| GLP-I RA | Proportion of Initiators for MarketScan Patients | Non-naive new users | 10.6 Percentage of participants |
| GLP-I RA | Proportion of Initiators for MarketScan Patients | Monotherapy | 3.4 Percentage of participants |
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.
Time frame: up to 12 months
Population: All subjects in the United Healthcare cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glitazones | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 6.5 Percentage of participants |
| Glitazones | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 10.0 Percentage of participants |
| Glitazones | Proportion of Initiators for United Healthcare Patients | Naive new users | 2.8 Percentage of participants |
| Glitazones | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 3.8 Percentage of participants |
| Glitazones | Proportion of Initiators for United Healthcare Patients | Monotherapy | 2.4 Percentage of participants |
| Linagliptin | Proportion of Initiators for United Healthcare Patients | Monotherapy | 1.2 Percentage of participants |
| Linagliptin | Proportion of Initiators for United Healthcare Patients | Naive new users | 0.5 Percentage of participants |
| Linagliptin | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 3.7 Percentage of participants |
| Linagliptin | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 3.1 Percentage of participants |
| Linagliptin | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 1.3 Percentage of participants |
| Meglitinides | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 0.3 Percentage of participants |
| Meglitinides | Proportion of Initiators for United Healthcare Patients | Monotherapy | 0.4 Percentage of participants |
| Meglitinides | Proportion of Initiators for United Healthcare Patients | Naive new users | 0.2 Percentage of participants |
| Meglitinides | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 2.1 Percentage of participants |
| Meglitinides | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 1.3 Percentage of participants |
| Metformin | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 13.0 Percentage of participants |
| Metformin | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 23.0 Percentage of participants |
| Metformin | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 41.8 Percentage of participants |
| Metformin | Proportion of Initiators for United Healthcare Patients | Naive new users | 69.9 Percentage of participants |
| Metformin | Proportion of Initiators for United Healthcare Patients | Monotherapy | 67.4 Percentage of participants |
| Saxagliptin | Proportion of Initiators for United Healthcare Patients | Monotherapy | 2.5 Percentage of participants |
| Saxagliptin | Proportion of Initiators for United Healthcare Patients | Naive new users | 2.3 Percentage of participants |
| Saxagliptin | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 8.2 Percentage of participants |
| Saxagliptin | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 6.3 Percentage of participants |
| Saxagliptin | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 9.1 Percentage of participants |
| Sitagliptin | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 18.2 Percentage of participants |
| Sitagliptin | Proportion of Initiators for United Healthcare Patients | Monotherapy | 6.0 Percentage of participants |
| Sitagliptin | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 13.6 Percentage of participants |
| Sitagliptin | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 21.3 Percentage of participants |
| Sitagliptin | Proportion of Initiators for United Healthcare Patients | Naive new users | 5.8 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for United Healthcare Patients | Monotherapy | 15.9 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 27.5 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for United Healthcare Patients | Naive new users | 16.3 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 28.5 Percentage of participants |
| Sulfonylurea | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 24.5 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for United Healthcare Patients | Monotherapy | 0.2 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 0.5 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 0.9 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 0.1 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Proportion of Initiators for United Healthcare Patients | Naive new users | 0.1 Percentage of participants |
| GLP-I RA | Proportion of Initiators for United Healthcare Patients | Other initiation other than mono- or dual therapy | 15.3 Percentage of participants |
| GLP-I RA | Proportion of Initiators for United Healthcare Patients | Naive new users | 2.1 Percentage of participants |
| GLP-I RA | Proportion of Initiators for United Healthcare Patients | Dual Therapy | 4.3 Percentage of participants |
| GLP-I RA | Proportion of Initiators for United Healthcare Patients | Non-naive new users | 11.6 Percentage of participants |
| GLP-I RA | Proportion of Initiators for United Healthcare Patients | Monotherapy | 4.1 Percentage of participants |
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
Time frame: up to 12 months
Population: All patients in MarketScan cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Subsequent Insulin Initiation for MarketScan Patients | 109.1 participants/1000 participant years |
| Linagliptin | Subsequent Insulin Initiation for MarketScan Patients | 111.02 participants/1000 participant years |
| Meglitinides | Subsequent Insulin Initiation for MarketScan Patients | 168.83 participants/1000 participant years |
| Metformin | Subsequent Insulin Initiation for MarketScan Patients | 57.99 participants/1000 participant years |
| Saxagliptin | Subsequent Insulin Initiation for MarketScan Patients | 105.7 participants/1000 participant years |
| Sitagliptin | Subsequent Insulin Initiation for MarketScan Patients | 103.65 participants/1000 participant years |
| Sulfonylurea | Subsequent Insulin Initiation for MarketScan Patients | 89.57 participants/1000 participant years |
| Alpha-Glucosidase Inhibitors | Subsequent Insulin Initiation for MarketScan Patients | 103.85 participants/1000 participant years |
| GLP-I RA | Subsequent Insulin Initiation for MarketScan Patients | 191.54 participants/1000 participant years |
| GLP-I RA | Subsequent Insulin Initiation for MarketScan Patients | 136.56 participants/1000 participant years |
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
Time frame: up to 12 months
Population: All patients in United Healthcare cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Subsequent Insulin Initiation for United Healthcare Patients | 112.61 participants/1000 participant years |
| Linagliptin | Subsequent Insulin Initiation for United Healthcare Patients | 101.17 participants/1000 participant years |
| Meglitinides | Subsequent Insulin Initiation for United Healthcare Patients | 162.97 participants/1000 participant years |
| Metformin | Subsequent Insulin Initiation for United Healthcare Patients | 56.49 participants/1000 participant years |
| Saxagliptin | Subsequent Insulin Initiation for United Healthcare Patients | 97.37 participants/1000 participant years |
| Sitagliptin | Subsequent Insulin Initiation for United Healthcare Patients | 103.26 participants/1000 participant years |
| Sulfonylurea | Subsequent Insulin Initiation for United Healthcare Patients | 92.02 participants/1000 participant years |
| Alpha-Glucosidase Inhibitors | Subsequent Insulin Initiation for United Healthcare Patients | 101.44 participants/1000 participant years |
| GLP-I RA | Subsequent Insulin Initiation for United Healthcare Patients | 142.42 participants/1000 participant years |
| GLP-I RA | Subsequent Insulin Initiation for United Healthcare Patients | 135.58 participants/1000 participant years |
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
Time frame: up to 12 months
Population: All patients in MarketScan cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Treatment Augmentation for MarketScan Patients | 310.93 participants/1000 participant years |
| Linagliptin | Treatment Augmentation for MarketScan Patients | 309.36 participants/1000 participant years |
| Meglitinides | Treatment Augmentation for MarketScan Patients | 269.53 participants/1000 participant years |
| Metformin | Treatment Augmentation for MarketScan Patients | 201.04 participants/1000 participant years |
| Saxagliptin | Treatment Augmentation for MarketScan Patients | 275.57 participants/1000 participant years |
| Sitagliptin | Treatment Augmentation for MarketScan Patients | 237.31 participants/1000 participant years |
| Sulfonylurea | Treatment Augmentation for MarketScan Patients | 226.11 participants/1000 participant years |
| Alpha-Glucosidase Inhibitors | Treatment Augmentation for MarketScan Patients | 248.28 participants/1000 participant years |
| GLP-I RA | Treatment Augmentation for MarketScan Patients | 287.85 participants/1000 participant years |
| GLP-I RA | Treatment Augmentation for MarketScan Patients | 184.84 participants/1000 participant years |
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
Time frame: up to 12 months
Population: All patients in United Healthcare cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Treatment Augmentation for United Healthcare Patients | 308.04 participants/1000 participant years |
| Linagliptin | Treatment Augmentation for United Healthcare Patients | 274.68 participants/1000 participant years |
| Meglitinides | Treatment Augmentation for United Healthcare Patients | 331.17 participants/1000 participant years |
| Metformin | Treatment Augmentation for United Healthcare Patients | 204.43 participants/1000 participant years |
| Saxagliptin | Treatment Augmentation for United Healthcare Patients | 269.02 participants/1000 participant years |
| Sitagliptin | Treatment Augmentation for United Healthcare Patients | 340.69 participants/1000 participant years |
| Sulfonylurea | Treatment Augmentation for United Healthcare Patients | 252.08 participants/1000 participant years |
| Alpha-Glucosidase Inhibitors | Treatment Augmentation for United Healthcare Patients | 317.89 participants/1000 participant years |
| GLP-I RA | Treatment Augmentation for United Healthcare Patients | 330.95 participants/1000 participant years |
| GLP-I RA | Treatment Augmentation for United Healthcare Patients | 199.60 participants/1000 participant years |
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
Time frame: up to 12 months
Population: All subjects in MarketScan cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Treatment Switching for MarketScan Patients | 110.35 participants/1000 participant years |
| Linagliptin | Treatment Switching for MarketScan Patients | 72.48 participants/1000 participant years |
| Meglitinides | Treatment Switching for MarketScan Patients | 96.88 participants/1000 participant years |
| Metformin | Treatment Switching for MarketScan Patients | 27.81 participants/1000 participant years |
| Saxagliptin | Treatment Switching for MarketScan Patients | 60.31 participants/1000 participant years |
| Sitagliptin | Treatment Switching for MarketScan Patients | 52.25 participants/1000 participant years |
| Sulfonylurea | Treatment Switching for MarketScan Patients | 40.87 participants/1000 participant years |
| Alpha-Glucosidase Inhibitors | Treatment Switching for MarketScan Patients | 54.33 participants/1000 participant years |
| GLP-I RA | Treatment Switching for MarketScan Patients | 102.9 participants/1000 participant years |
| GLP-I RA | Treatment Switching for MarketScan Patients | 67.1 participants/1000 participant years |
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
Time frame: up to 12 months
Population: All subjects in United Healthcare cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Treatment Switching for United Healthcare Patients | 117.76 participants/1000 participant years |
| Linagliptin | Treatment Switching for United Healthcare Patients | 71.64 participants/1000 participant years |
| Meglitinides | Treatment Switching for United Healthcare Patients | 122.97 participants/1000 participant years |
| Metformin | Treatment Switching for United Healthcare Patients | 30.47 participants/1000 participant years |
| Saxagliptin | Treatment Switching for United Healthcare Patients | 57.38 participants/1000 participant years |
| Sitagliptin | Treatment Switching for United Healthcare Patients | 103.09 participants/1000 participant years |
| Sulfonylurea | Treatment Switching for United Healthcare Patients | 46.89 participants/1000 participant years |
| Alpha-Glucosidase Inhibitors | Treatment Switching for United Healthcare Patients | 87.6 participants/1000 participant years |
| GLP-I RA | Treatment Switching for United Healthcare Patients | 126.83 participants/1000 participant years |
| GLP-I RA | Treatment Switching for United Healthcare Patients | 77.9 participants/1000 participant years |
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.
Time frame: 12 months
Population: All patients in MarketScan cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Persistence at 12 Months for MarketScan Patients | 29.04 Percentage of participants |
| Linagliptin | Persistence at 12 Months for MarketScan Patients | 50.30 Percentage of participants |
| Meglitinides | Persistence at 12 Months for MarketScan Patients | 27.18 Percentage of participants |
| Metformin | Persistence at 12 Months for MarketScan Patients | 39.32 Percentage of participants |
| Saxagliptin | Persistence at 12 Months for MarketScan Patients | 50.15 Percentage of participants |
| Sitagliptin | Persistence at 12 Months for MarketScan Patients | 46.83 Percentage of participants |
| Sulfonylurea | Persistence at 12 Months for MarketScan Patients | 41.60 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Persistence at 12 Months for MarketScan Patients | 47.95 Percentage of participants |
| GLP-I RA | Persistence at 12 Months for MarketScan Patients | 27.27 Percentage of participants |
| GLP-I RA | Persistence at 12 Months for MarketScan Patients | 35.81 Percentage of participants |
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.
Time frame: 12 months
Population: All patients in United Healthcare cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Persistence at 12 Months for United Healthcare Patients | 28.35 Percentage of participants |
| Linagliptin | Persistence at 12 Months for United Healthcare Patients | 51.45 Percentage of participants |
| Meglitinides | Persistence at 12 Months for United Healthcare Patients | 22.64 Percentage of participants |
| Metformin | Persistence at 12 Months for United Healthcare Patients | 35.45 Percentage of participants |
| Saxagliptin | Persistence at 12 Months for United Healthcare Patients | 49.75 Percentage of participants |
| Sitagliptin | Persistence at 12 Months for United Healthcare Patients | 36.84 Percentage of participants |
| Sulfonylurea | Persistence at 12 Months for United Healthcare Patients | 38.58 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Persistence at 12 Months for United Healthcare Patients | 40.95 Percentage of participants |
| GLP-I RA | Persistence at 12 Months for United Healthcare Patients | 25.05 Percentage of participants |
| GLP-I RA | Persistence at 12 Months for United Healthcare Patients | 33.58 Percentage of participants |
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.
Time frame: 3 months
Population: All patients in MarketScan cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Persistence at 3 Months for MarketScan Patients | 73.47 Percentage of participants |
| Linagliptin | Persistence at 3 Months for MarketScan Patients | 83.39 Percentage of participants |
| Meglitinides | Persistence at 3 Months for MarketScan Patients | 68.90 Percentage of participants |
| Metformin | Persistence at 3 Months for MarketScan Patients | 76.89 Percentage of participants |
| Saxagliptin | Persistence at 3 Months for MarketScan Patients | 82.82 Percentage of participants |
| Sitagliptin | Persistence at 3 Months for MarketScan Patients | 81.58 Percentage of participants |
| Sulfonylurea | Persistence at 3 Months for MarketScan Patients | 78.72 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Persistence at 3 Months for MarketScan Patients | 82.12 Percentage of participants |
| GLP-I RA | Persistence at 3 Months for MarketScan Patients | 69.08 Percentage of participants |
| GLP-I RA | Persistence at 3 Months for MarketScan Patients | 73.05 Percentage of participants |
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.
Time frame: 3 months
Population: All patients in United Healthcare cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Persistence at 3 Months for United Healthcare Patients | 68.90 Percentage of participants |
| Linagliptin | Persistence at 3 Months for United Healthcare Patients | 82.84 Percentage of participants |
| Meglitinides | Persistence at 3 Months for United Healthcare Patients | 59.12 Percentage of participants |
| Metformin | Persistence at 3 Months for United Healthcare Patients | 70.63 Percentage of participants |
| Saxagliptin | Persistence at 3 Months for United Healthcare Patients | 81.40 Percentage of participants |
| Sitagliptin | Persistence at 3 Months for United Healthcare Patients | 77.27 Percentage of participants |
| Sulfonylurea | Persistence at 3 Months for United Healthcare Patients | 73.2 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Persistence at 3 Months for United Healthcare Patients | 78.79 Percentage of participants |
| GLP-I RA | Persistence at 3 Months for United Healthcare Patients | 65.86 Percentage of participants |
| GLP-I RA | Persistence at 3 Months for United Healthcare Patients | 68.98 Percentage of participants |
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.
Time frame: 6 months
Population: All patients in MarketScan cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Persistence at 6 Months for MarketScan Patients | 42.70 Percentage of participants |
| Linagliptin | Persistence at 6 Months for MarketScan Patients | 62.91 Percentage of participants |
| Meglitinides | Persistence at 6 Months for MarketScan Patients | 39.32 Percentage of participants |
| Metformin | Persistence at 6 Months for MarketScan Patients | 51.37 Percentage of participants |
| Saxagliptin | Persistence at 6 Months for MarketScan Patients | 63.07 Percentage of participants |
| Sitagliptin | Persistence at 6 Months for MarketScan Patients | 59.54 Percentage of participants |
| Sulfonylurea | Persistence at 6 Months for MarketScan Patients | 53.87 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Persistence at 6 Months for MarketScan Patients | 60.80 Percentage of participants |
| GLP-I RA | Persistence at 6 Months for MarketScan Patients | 39.62 Percentage of participants |
| GLP-I RA | Persistence at 6 Months for MarketScan Patients | 48.40 Percentage of participants |
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.
Time frame: 6 months
Population: All patients in United Healthcare cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Persistence at 6 Months for United Healthcare Patients | 42.02 Percentage of participants |
| Linagliptin | Persistence at 6 Months for United Healthcare Patients | 64.65 Percentage of participants |
| Meglitinides | Persistence at 6 Months for United Healthcare Patients | 34.29 Percentage of participants |
| Metformin | Persistence at 6 Months for United Healthcare Patients | 48.38 Percentage of participants |
| Saxagliptin | Persistence at 6 Months for United Healthcare Patients | 62.90 Percentage of participants |
| Sitagliptin | Persistence at 6 Months for United Healthcare Patients | 55.41 Percentage of participants |
| Sulfonylurea | Persistence at 6 Months for United Healthcare Patients | 51.71 Percentage of participants |
| Alpha-Glucosidase Inhibitors | Persistence at 6 Months for United Healthcare Patients | 57.95 Percentage of participants |
| GLP-I RA | Persistence at 6 Months for United Healthcare Patients | 39.80 Percentage of participants |
| GLP-I RA | Persistence at 6 Months for United Healthcare Patients | 47.25 Percentage of participants |
Secondary
Proportion of Days Covered for MarketScan Patients
Number of days supply dispensed divided by number of days followed
Time frame: up to 12 months
Population: All patients in MarketScan cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glitazones | Proportion of Days Covered for MarketScan Patients | 72.04 days covered | Standard Deviation 19.82 |
| Linagliptin | Proportion of Days Covered for MarketScan Patients | 78.62 days covered | Standard Deviation 19.15 |
| Meglitinides | Proportion of Days Covered for MarketScan Patients | 69.58 days covered | Standard Deviation 20.56 |
| Metformin | Proportion of Days Covered for MarketScan Patients | 74.40 days covered | Standard Deviation 20.2 |
| Saxagliptin | Proportion of Days Covered for MarketScan Patients | 78.13 days covered | Standard Deviation 19.34 |
| Sitagliptin | Proportion of Days Covered for MarketScan Patients | 77.80 days covered | Standard Deviation 19.78 |
| Sulfonylurea | Proportion of Days Covered for MarketScan Patients | 76.09 days covered | Standard Deviation 20.28 |
| Alpha-Glucosidase Inhibitors | Proportion of Days Covered for MarketScan Patients | 78.00 days covered | Standard Deviation 19.61 |
| GLP-I RA | Proportion of Days Covered for MarketScan Patients | 69.82 days covered | Standard Deviation 20.38 |
| GLP-I RA | Proportion of Days Covered for MarketScan Patients | 71.30 days covered | Standard Deviation 20.23 |
Secondary
Proportion of Days Covered for United Healthcare Patients
Number of days supply dispensed divided by number of days followed
Time frame: up to 12 months
Population: All patients in United Healthcare cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glitazones | Proportion of Days Covered for United Healthcare Patients | 68.79 days covered | Standard Deviation 19.68 |
| Linagliptin | Proportion of Days Covered for United Healthcare Patients | 77.54 days covered | Standard Deviation 18.91 |
| Meglitinides | Proportion of Days Covered for United Healthcare Patients | 64.04 days covered | Standard Deviation 19.94 |
| Metformin | Proportion of Days Covered for United Healthcare Patients | 70.37 days covered | Standard Deviation 20.31 |
| Saxagliptin | Proportion of Days Covered for United Healthcare Patients | 75.81 days covered | Standard Deviation 19.3 |
| Sitagliptin | Proportion of Days Covered for United Healthcare Patients | 73.09 days covered | Standard Deviation 19.3 |
| Sulfonylurea | Proportion of Days Covered for United Healthcare Patients | 72.46 days covered | Standard Deviation 20.58 |
| Alpha-Glucosidase Inhibitors | Proportion of Days Covered for United Healthcare Patients | 74.03 days covered | Standard Deviation 19.32 |
| GLP-I RA | Proportion of Days Covered for United Healthcare Patients | 67.48 days covered | Standard Deviation 19.62 |
| GLP-I RA | Proportion of Days Covered for United Healthcare Patients | 68.34 days covered | Standard Deviation 19.66 |
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)
Time frame: up to 12 months
Population: All subjects in Marketscan cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Treatment Discontinuation for Marketscan Patients | 522.1 participants/1000 participant years |
| Linagliptin | Treatment Discontinuation for Marketscan Patients | 284.67 participants/1000 participant years |
| Meglitinides | Treatment Discontinuation for Marketscan Patients | 463.13 participants/1000 participant years |
| Metformin | Treatment Discontinuation for Marketscan Patients | 285.58 participants/1000 participant years |
| Saxagliptin | Treatment Discontinuation for Marketscan Patients | 261.2 participants/1000 participant years |
| Sitagliptin | Treatment Discontinuation for Marketscan Patients | 262.24 participants/1000 participant years |
| Sulfonylurea | Treatment Discontinuation for Marketscan Patients | 285.75 participants/1000 participant years |
| Alpha-Glucosidase Inhibitors | Treatment Discontinuation for Marketscan Patients | 261.06 participants/1000 participant years |
| GLP-I RA | Treatment Discontinuation for Marketscan Patients | 504.83 participants/1000 participant years |
| GLP-I RA | Treatment Discontinuation for Marketscan Patients | 333.9 participants/1000 participant years |
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)
Time frame: up to 12 months
Population: All subjects in United Healthcare cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glitazones | Treatment Discontinuation for United Healthcare Patients | 523.32 participants/1000 participant years |
| Linagliptin | Treatment Discontinuation for United Healthcare Patients | 287.61 participants/1000 participant years |
| Meglitinides | Treatment Discontinuation for United Healthcare Patients | 466.55 participants/1000 participant years |
| Metformin | Treatment Discontinuation for United Healthcare Patients | 293.23 participants/1000 participant years |
| Saxagliptin | Treatment Discontinuation for United Healthcare Patients | 267.60 participants/1000 participant years |
| Sitagliptin | Treatment Discontinuation for United Healthcare Patients | 267.75 participants/1000 participant years |
| Sulfonylurea | Treatment Discontinuation for United Healthcare Patients | 288.55 participants/1000 participant years |
| Alpha-Glucosidase Inhibitors | Treatment Discontinuation for United Healthcare Patients | 266.83 participants/1000 participant years |
| GLP-I RA | Treatment Discontinuation for United Healthcare Patients | 479.31 participants/1000 participant years |
| GLP-I RA | Treatment Discontinuation for United Healthcare Patients | 337.30 participants/1000 participant years |