Trial Outcomes & Findings for Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns (NCT NCT02138097)

Results Overview

Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.

Recruitment status

COMPLETED

Target enrollment

615067 participants

Primary outcome timeframe

up to 12 months

Results posted on

2015-10-06

Participant Flow

Existing data cohort design using data from the United Healthcare and MarketScan databases from May 2011 through July 2012

Participant milestones

Participant milestones
Measure	United Healthcare Patients using an oral and non-insulin injected glucose-lowering medication identified from the United Healthcare Research database	MarketScan Patients using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
Overall Study STARTED	155345	459722
Overall Study COMPLETED	155345	459722
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UHC: Glitazones n=7203 Participants Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication.	UHC: Linagliptin n=2820 Participants Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	UHC: Meglitinides n=1184 Participants Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	UHC: Metformin n=72694 Participants Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.	UHC: Saxagliptin n=8100 Participants Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	UHC: Sitagliptin n=18491 Participants Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	UHC: Sulfonylurea n=33868 Participants Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	UHC: Alpha-Glucosidase Inhibitors n=495 Participants Patients in the United Healthcare cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	UHC: GLP-I RA n=10490 Participants 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.	MS: Linagliptin n=7708 Participants Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	MS: Sitagliptin n=58769 Participants Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	MS: Saxagliptin n=24550 Participants Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	MS: Metformin n=205213 Participants Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.	MS: Sulfonylurea n=104422 Participants Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	MS: Glitazones n=22310 Participants Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication.	MS: Meglitinides n=5412 Participants Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	MS: Alpha-Glucosidase Inhibitors n=1918 Participants Patients in the MarketScan (MS) cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	MS: GLP-I RA n=29420 Participants 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.	Total n=615067 Participants Total of all reporting groups
Age, Continuous	53.67 years STANDARD_DEVIATION 9.99 • n=5 Participants	55.90 years STANDARD_DEVIATION 10.06 • n=7 Participants	57.08 years STANDARD_DEVIATION 10.46 • n=5 Participants	52.57 years STANDARD_DEVIATION 10.56 • n=4 Participants	53.68 years STANDARD_DEVIATION 9.66 • n=21 Participants	54.40 years STANDARD_DEVIATION 10.16 • n=8 Participants	53.75 years STANDARD_DEVIATION 10.40 • n=8 Participants	55.93 years STANDARD_DEVIATION 10.67 • n=24 Participants	52.35 years STANDARD_DEVIATION 9.54 • n=42 Participants	58.72 years STANDARD_DEVIATION 11.66 • n=42 Participants	58.42 years STANDARD_DEVIATION 11.98 • n=42 Participants	56.84 years STANDARD_DEVIATION 11.39 • n=42 Participants	55.91 years STANDARD_DEVIATION 12.08 • n=36 Participants	57.94 years STANDARD_DEVIATION 12.49 • n=36 Participants	57.40 years STANDARD_DEVIATION 11.66 • n=24 Participants	62.50 years STANDARD_DEVIATION 12.60 • n=135 Participants	59.96 years STANDARD_DEVIATION 12.00 • n=136 Participants	54.28 years STANDARD_DEVIATION 10.02 • n=44 Participants	55.05 years STANDARD_DEVIATION 11.22 • n=667 Participants
Sex: Female, Male Female	2679 Participants n=5 Participants	1175 Participants n=7 Participants	505 Participants n=5 Participants	32251 Participants n=4 Participants	3400 Participants n=21 Participants	7600 Participants n=8 Participants	13631 Participants n=8 Participants	201 Participants n=24 Participants	5521 Participants n=42 Participants	3368 Participants n=42 Participants	26158 Participants n=42 Participants	10838 Participants n=42 Participants	97105 Participants n=36 Participants	45668 Participants n=36 Participants	9181 Participants n=24 Participants	2526 Participants n=135 Participants	909 Participants n=136 Participants	16077 Participants n=44 Participants	278793 Participants n=667 Participants
Sex: Female, Male Male	4524 Participants n=5 Participants	1645 Participants n=7 Participants	679 Participants n=5 Participants	40443 Participants n=4 Participants	4700 Participants n=21 Participants	10891 Participants n=8 Participants	20237 Participants n=8 Participants	294 Participants n=24 Participants	4969 Participants n=42 Participants	4340 Participants n=42 Participants	32611 Participants n=42 Participants	13712 Participants n=42 Participants	108108 Participants n=36 Participants	58754 Participants n=36 Participants	13129 Participants n=24 Participants	2886 Participants n=135 Participants	1009 Participants n=136 Participants	13343 Participants n=44 Participants	336274 Participants n=667 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: All subjects in the United Healthcare cohort

Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=495 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Proportion of Initiators for United Healthcare Patients Naive new users	2.8 Percentage of participants	0.5 Percentage of participants	0.2 Percentage of participants	69.9 Percentage of participants	2.3 Percentage of participants	5.8 Percentage of participants	16.3 Percentage of participants	0.1 Percentage of participants	2.1 Percentage of participants	—
Proportion of Initiators for United Healthcare Patients Non-naive new users	6.5 Percentage of participants	3.1 Percentage of participants	1.3 Percentage of participants	23.0 Percentage of participants	8.2 Percentage of participants	18.2 Percentage of participants	27.5 Percentage of participants	0.5 Percentage of participants	11.6 Percentage of participants	—
Proportion of Initiators for United Healthcare Patients Monotherapy	2.4 Percentage of participants	1.2 Percentage of participants	0.4 Percentage of participants	67.4 Percentage of participants	2.5 Percentage of participants	6.0 Percentage of participants	15.9 Percentage of participants	0.2 Percentage of participants	4.1 Percentage of participants	—
Proportion of Initiators for United Healthcare Patients Dual Therapy	3.8 Percentage of participants	1.3 Percentage of participants	0.3 Percentage of participants	41.8 Percentage of participants	6.3 Percentage of participants	13.6 Percentage of participants	28.5 Percentage of participants	0.1 Percentage of participants	4.3 Percentage of participants	—
Proportion of Initiators for United Healthcare Patients Other initiation other than mono- or dual therapy	10.0 Percentage of participants	3.7 Percentage of participants	2.1 Percentage of participants	13.0 Percentage of participants	9.1 Percentage of participants	21.3 Percentage of participants	24.5 Percentage of participants	0.9 Percentage of participants	15.3 Percentage of participants	—

PRIMARY outcome

Timeframe: up to 12 months

Population: All subjects in MarketScan cohort

Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=1918 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Proportion of Initiators for MarketScan Patients Naive new users	3.0 Percentage of participants	0.4 Percentage of participants	0.4 Percentage of participants	69.1 Percentage of participants	2.1 Percentage of participants	5.9 Percentage of participants	17.2 Percentage of participants	0.1 Percentage of participants	1.6 Percentage of participants	—
Proportion of Initiators for MarketScan Patients Non-naive new users	6.5 Percentage of participants	2.8 Percentage of participants	1.9 Percentage of participants	23.2 Percentage of participants	8.1 Percentage of participants	18.8 Percentage of participants	27.5 Percentage of participants	0.7 Percentage of participants	10.6 Percentage of participants	—
Proportion of Initiators for MarketScan Patients Monotherapy	2.5 Percentage of participants	1.0 Percentage of participants	0.6 Percentage of participants	66.1 Percentage of participants	2.6 Percentage of participants	6.3 Percentage of participants	17.4 Percentage of participants	0.2 Percentage of participants	3.4 Percentage of participants	—
Proportion of Initiators for MarketScan Patients Dual Therapy	5.1 Percentage of participants	1.7 Percentage of participants	1.0 Percentage of participants	34.0 Percentage of participants	6.6 Percentage of participants	15.6 Percentage of participants	29.7 Percentage of participants	0.3 Percentage of participants	5.8 Percentage of participants	—
Proportion of Initiators for MarketScan Patients Other initiation other than mono- or dual therapy	9.6 Percentage of participants	3.0 Percentage of participants	2.7 Percentage of participants	16.9 Percentage of participants	9.0 Percentage of participants	21.8 Percentage of participants	21.4 Percentage of participants	1.1 Percentage of participants	14.5 Percentage of participants	—

PRIMARY outcome

Timeframe: up to 12 months

Population: All subjects in United Healthcare cohort

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

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=25940 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=495 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Treatment Switching for United Healthcare Patients	117.76 participants/1000 participant years	71.64 participants/1000 participant years	122.97 participants/1000 participant years	30.47 participants/1000 participant years	57.38 participants/1000 participant years	103.09 participants/1000 participant years	46.89 participants/1000 participant years	87.6 participants/1000 participant years	126.83 participants/1000 participant years	77.9 participants/1000 participant years

PRIMARY outcome

Timeframe: up to 12 months

Population: All subjects in MarketScan cohort

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

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=81760 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=1918 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Treatment Switching for MarketScan Patients	110.35 participants/1000 participant years	72.48 participants/1000 participant years	96.88 participants/1000 participant years	27.81 participants/1000 participant years	60.31 participants/1000 participant years	52.25 participants/1000 participant years	40.87 participants/1000 participant years	54.33 participants/1000 participant years	102.9 participants/1000 participant years	67.1 participants/1000 participant years

PRIMARY outcome

Timeframe: up to 12 months

Population: All patients in United Healthcare cohort

Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=25940 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=495 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Treatment Augmentation for United Healthcare Patients	308.04 participants/1000 participant years	274.68 participants/1000 participant years	331.17 participants/1000 participant years	204.43 participants/1000 participant years	269.02 participants/1000 participant years	340.69 participants/1000 participant years	252.08 participants/1000 participant years	317.89 participants/1000 participant years	330.95 participants/1000 participant years	199.60 participants/1000 participant years

PRIMARY outcome

Timeframe: up to 12 months

Population: All patients in MarketScan cohort

Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=81760 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=1918 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Treatment Augmentation for MarketScan Patients	310.93 participants/1000 participant years	309.36 participants/1000 participant years	269.53 participants/1000 participant years	201.04 participants/1000 participant years	275.57 participants/1000 participant years	237.31 participants/1000 participant years	226.11 participants/1000 participant years	248.28 participants/1000 participant years	287.85 participants/1000 participant years	184.84 participants/1000 participant years

PRIMARY outcome

Timeframe: up to 12 months

Population: All patients in United Healthcare cohort

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

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=25940 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=495 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Subsequent Insulin Initiation for United Healthcare Patients	112.61 participants/1000 participant years	101.17 participants/1000 participant years	162.97 participants/1000 participant years	56.49 participants/1000 participant years	97.37 participants/1000 participant years	103.26 participants/1000 participant years	92.02 participants/1000 participant years	101.44 participants/1000 participant years	142.42 participants/1000 participant years	135.58 participants/1000 participant years

PRIMARY outcome

Timeframe: up to 12 months

Population: All patients in MarketScan cohort

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

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=81760 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=1918 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Subsequent Insulin Initiation for MarketScan Patients	109.1 participants/1000 participant years	111.02 participants/1000 participant years	168.83 participants/1000 participant years	57.99 participants/1000 participant years	105.7 participants/1000 participant years	103.65 participants/1000 participant years	89.57 participants/1000 participant years	103.85 participants/1000 participant years	191.54 participants/1000 participant years	136.56 participants/1000 participant years

SECONDARY outcome

Timeframe: up to 12 months

Population: All subjects in United Healthcare cohort

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)

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=25940 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=495 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Treatment Discontinuation for United Healthcare Patients	523.32 participants/1000 participant years	287.61 participants/1000 participant years	466.55 participants/1000 participant years	293.23 participants/1000 participant years	267.60 participants/1000 participant years	267.75 participants/1000 participant years	288.55 participants/1000 participant years	266.83 participants/1000 participant years	479.31 participants/1000 participant years	337.30 participants/1000 participant years

SECONDARY outcome

Timeframe: up to 12 months

Population: All subjects in Marketscan cohort

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)

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=81760 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=1918 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Treatment Discontinuation for Marketscan Patients	522.1 participants/1000 participant years	284.67 participants/1000 participant years	463.13 participants/1000 participant years	285.58 participants/1000 participant years	261.2 participants/1000 participant years	262.24 participants/1000 participant years	285.75 participants/1000 participant years	261.06 participants/1000 participant years	504.83 participants/1000 participant years	333.9 participants/1000 participant years

SECONDARY outcome

Timeframe: up to 12 months

Population: All patients in United Healthcare cohort

Number of days supply dispensed divided by number of days followed

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=25940 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=495 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Proportion of Days Covered for United Healthcare Patients	68.79 days covered Standard Deviation 19.68	77.54 days covered Standard Deviation 18.91	64.04 days covered Standard Deviation 19.94	70.37 days covered Standard Deviation 20.31	75.81 days covered Standard Deviation 19.30	73.09 days covered Standard Deviation 19.30	72.46 days covered Standard Deviation 20.58	74.03 days covered Standard Deviation 19.32	67.48 days covered Standard Deviation 19.62	68.34 days covered Standard Deviation 19.66

SECONDARY outcome

Timeframe: up to 12 months

Population: All patients in MarketScan cohort

Number of days supply dispensed divided by number of days followed

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=81760 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=1918 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Proportion of Days Covered for MarketScan Patients	72.04 days covered Standard Deviation 19.82	78.62 days covered Standard Deviation 19.15	69.58 days covered Standard Deviation 20.56	74.40 days covered Standard Deviation 20.20	78.13 days covered Standard Deviation 19.34	77.80 days covered Standard Deviation 19.78	76.09 days covered Standard Deviation 20.28	78.00 days covered Standard Deviation 19.61	69.82 days covered Standard Deviation 20.38	71.30 days covered Standard Deviation 20.23

SECONDARY outcome

Timeframe: 3 months

Population: All patients in United Healthcare cohort

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.

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=25940 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=495 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Persistence at 3 Months for United Healthcare Patients	68.90 Percentage of participants	82.84 Percentage of participants	59.12 Percentage of participants	70.63 Percentage of participants	81.40 Percentage of participants	77.27 Percentage of participants	73.2 Percentage of participants	78.79 Percentage of participants	65.86 Percentage of participants	68.98 Percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: All patients in United Healthcare cohort

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.

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=25940 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=495 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Persistence at 6 Months for United Healthcare Patients	42.02 Percentage of participants	64.65 Percentage of participants	34.29 Percentage of participants	48.38 Percentage of participants	62.90 Percentage of participants	55.41 Percentage of participants	51.71 Percentage of participants	57.95 Percentage of participants	39.80 Percentage of participants	47.25 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: All patients in United Healthcare cohort

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.

Outcome measures

Outcome measures
Measure	Glitazones n=7203 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=2820 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=1184 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=72694 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=8100 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=18491 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=33868 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=25940 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=495 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=10490 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Persistence at 12 Months for United Healthcare Patients	28.35 Percentage of participants	51.45 Percentage of participants	22.64 Percentage of participants	35.45 Percentage of participants	49.75 Percentage of participants	36.84 Percentage of participants	38.58 Percentage of participants	40.95 Percentage of participants	25.05 Percentage of participants	33.58 Percentage of participants

SECONDARY outcome

Timeframe: 3 months

Population: All patients in MarketScan cohort

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.

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=81760 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=1918 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Persistence at 3 Months for MarketScan Patients	73.47 Percentage of participants	83.39 Percentage of participants	68.90 Percentage of participants	76.89 Percentage of participants	82.82 Percentage of participants	81.58 Percentage of participants	78.72 Percentage of participants	82.12 Percentage of participants	69.08 Percentage of participants	73.05 Percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: All patients in MarketScan cohort

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.

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=81760 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=1918 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Persistence at 6 Months for MarketScan Patients	42.70 Percentage of participants	62.91 Percentage of participants	39.32 Percentage of participants	51.37 Percentage of participants	63.07 Percentage of participants	59.54 Percentage of participants	53.87 Percentage of participants	60.80 Percentage of participants	39.62 Percentage of participants	48.40 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: All patients in MarketScan cohort

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.

Outcome measures

Outcome measures
Measure	Glitazones n=22310 Participants Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.	Linagliptin n=7708 Participants Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.	Meglitinides n=5412 Participants Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.	Metformin n=205213 Participants Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.	Saxagliptin n=24550 Participants Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.	Sitagliptin n=58769 Participants Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.	Sulfonylurea n=104422 Participants Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.	Alpha-Glucosidase Inhibitors n=81760 Participants Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=1918 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.	GLP-I RA n=29420 Participants Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Persistence at 12 Months for MarketScan Patients	29.04 Percentage of participants	50.30 Percentage of participants	27.18 Percentage of participants	39.32 Percentage of participants	50.15 Percentage of participants	46.83 Percentage of participants	41.60 Percentage of participants	47.95 Percentage of participants	27.27 Percentage of participants	35.81 Percentage of participants

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER