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Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

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ClinicalTrials.gov Identifier: NCT02138097
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : October 6, 2015
Last Update Posted : October 6, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Diabetes Mellitus, Type 2
Enrollment 615067
Recruitment Details Existing data cohort design using data from the United Healthcare and MarketScan databases from May 2011 through July 2012
Pre-assignment Details  
Arm/Group Title United Healthcare MarketScan
Hide Arm/Group Description Patients using an oral and non-insulin injected glucose-lowering medication identified from the United Healthcare Research database Patients using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
Period Title: Overall Study
Started 155345 459722
Completed 155345 459722
Not Completed 0 0
Arm/Group Title UHC: Glitazones 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 MS: GLP-I RA Total
Hide Arm/Group Description Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication. Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication. Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication. Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication. Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. Patients in the United Healthcare cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication. 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. Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication. Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication. Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication. Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication. Patients in the MarketScan (MS) cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication. 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 of all reporting groups
Overall Number of Baseline Participants 7203 2820 1184 72694 8100 18491 33868 495 10490 7708 58769 24550 205213 104422 22310 5412 1918 29420 615067
Hide Baseline Analysis Population Description
All patients included in the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7203 participants 2820 participants 1184 participants 72694 participants 8100 participants 18491 participants 33868 participants 495 participants 10490 participants 7708 participants 58769 participants 24550 participants 205213 participants 104422 participants 22310 participants 5412 participants 1918 participants 29420 participants 615067 participants
53.67  (9.99) 55.90  (10.06) 57.08  (10.46) 52.57  (10.56) 53.68  (9.66) 54.40  (10.16) 53.75  (10.40) 55.93  (10.67) 52.35  (9.54) 58.72  (11.66) 58.42  (11.98) 56.84  (11.39) 55.91  (12.08) 57.94  (12.49) 57.40  (11.66) 62.50  (12.60) 59.96  (12.00) 54.28  (10.02) 55.05  (11.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7203 participants 2820 participants 1184 participants 72694 participants 8100 participants 18491 participants 33868 participants 495 participants 10490 participants 7708 participants 58769 participants 24550 participants 205213 participants 104422 participants 22310 participants 5412 participants 1918 participants 29420 participants 615067 participants
Female
2679
  37.2%
1175
  41.7%
505
  42.7%
32251
  44.4%
3400
  42.0%
7600
  41.1%
13631
  40.2%
201
  40.6%
5521
  52.6%
3368
  43.7%
26158
  44.5%
10838
  44.1%
97105
  47.3%
45668
  43.7%
9181
  41.2%
2526
  46.7%
909
  47.4%
16077
  54.6%
278793
  45.3%
Male
4524
  62.8%
1645
  58.3%
679
  57.3%
40443
  55.6%
4700
  58.0%
10891
  58.9%
20237
  59.8%
294
  59.4%
4969
  47.4%
4340
  56.3%
32611
  55.5%
13712
  55.9%
108108
  52.7%
58754
  56.3%
13129
  58.8%
2886
  53.3%
1009
  52.6%
13343
  45.4%
336274
  54.7%
1.Primary Outcome
Title Proportion of Initiators for United Healthcare Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 495 10490
Measure Type: Number
Unit of Measure: Percentage of participants
Naive new users 2.8 0.5 0.2 69.9 2.3 5.8 16.3 0.1 2.1
Non-naive new users 6.5 3.1 1.3 23.0 8.2 18.2 27.5 0.5 11.6
Monotherapy 2.4 1.2 0.4 67.4 2.5 6.0 15.9 0.2 4.1
Dual Therapy 3.8 1.3 0.3 41.8 6.3 13.6 28.5 0.1 4.3
Other initiation other than mono- or dual therapy 10.0 3.7 2.1 13.0 9.1 21.3 24.5 0.9 15.3
2.Primary Outcome
Title Proportion of Initiators for MarketScan Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in MarketScan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 1918 29420
Measure Type: Number
Unit of Measure: Percentage of participants
Naive new users 3.0 0.4 0.4 69.1 2.1 5.9 17.2 0.1 1.6
Non-naive new users 6.5 2.8 1.9 23.2 8.1 18.8 27.5 0.7 10.6
Monotherapy 2.5 1.0 0.6 66.1 2.6 6.3 17.4 0.2 3.4
Dual Therapy 5.1 1.7 1.0 34.0 6.6 15.6 29.7 0.3 5.8
Other initiation other than mono- or dual therapy 9.6 3.0 2.7 16.9 9.0 21.8 21.4 1.1 14.5
3.Primary Outcome
Title Treatment Switching for United Healthcare Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 25940 495 10490
Measure Type: Number
Unit of Measure: participants/1000 participant years
117.76 71.64 122.97 30.47 57.38 103.09 46.89 87.6 126.83 77.9
4.Primary Outcome
Title Treatment Switching for MarketScan Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in MarketScan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 81760 1918 29420
Measure Type: Number
Unit of Measure: participants/1000 participant years
110.35 72.48 96.88 27.81 60.31 52.25 40.87 54.33 102.9 67.1
5.Primary Outcome
Title Treatment Augmentation for United Healthcare Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 25940 495 10490
Measure Type: Number
Unit of Measure: participants/1000 participant years
308.04 274.68 331.17 204.43 269.02 340.69 252.08 317.89 330.95 199.60
6.Primary Outcome
Title Treatment Augmentation for MarketScan Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in MarketScan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 81760 1918 29420
Measure Type: Number
Unit of Measure: participants/1000 participant years
310.93 309.36 269.53 201.04 275.57 237.31 226.11 248.28 287.85 184.84
7.Primary Outcome
Title Subsequent Insulin Initiation for United Healthcare Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 25940 495 10490
Measure Type: Number
Unit of Measure: participants/1000 participant years
112.61 101.17 162.97 56.49 97.37 103.26 92.02 101.44 142.42 135.58
8.Primary Outcome
Title Subsequent Insulin Initiation for MarketScan Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in MarketScan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 81760 1918 29420
Measure Type: Number
Unit of Measure: participants/1000 participant years
109.1 111.02 168.83 57.99 105.7 103.65 89.57 103.85 191.54 136.56
9.Secondary Outcome
Title Treatment Discontinuation for United Healthcare Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 25940 495 10490
Measure Type: Number
Unit of Measure: participants/1000 participant years
523.32 287.61 466.55 293.23 267.60 267.75 288.55 266.83 479.31 337.30
10.Secondary Outcome
Title Treatment Discontinuation for Marketscan Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in Marketscan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 81760 1918 29420
Measure Type: Number
Unit of Measure: participants/1000 participant years
522.1 284.67 463.13 285.58 261.2 262.24 285.75 261.06 504.83 333.9
11.Secondary Outcome
Title Proportion of Days Covered for United Healthcare Patients
Hide Description Number of days supply dispensed divided by number of days followed
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 25940 495 10490
Mean (Standard Deviation)
Unit of Measure: days covered
68.79  (19.68) 77.54  (18.91) 64.04  (19.94) 70.37  (20.31) 75.81  (19.30) 73.09  (19.30) 72.46  (20.58) 74.03  (19.32) 67.48  (19.62) 68.34  (19.66)
12.Secondary Outcome
Title Proportion of Days Covered for MarketScan Patients
Hide Description Number of days supply dispensed divided by number of days followed
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in MarketScan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 81760 1918 29420
Mean (Standard Deviation)
Unit of Measure: days covered
72.04  (19.82) 78.62  (19.15) 69.58  (20.56) 74.40  (20.20) 78.13  (19.34) 77.80  (19.78) 76.09  (20.28) 78.00  (19.61) 69.82  (20.38) 71.30  (20.23)
13.Secondary Outcome
Title Persistence at 3 Months for United Healthcare Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 25940 495 10490
Measure Type: Number
Unit of Measure: Percentage of participants
68.90 82.84 59.12 70.63 81.40 77.27 73.2 78.79 65.86 68.98
14.Secondary Outcome
Title Persistence at 6 Months for United Healthcare Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 25940 495 10490
Measure Type: Number
Unit of Measure: Percentage of participants
42.02 64.65 34.29 48.38 62.90 55.41 51.71 57.95 39.80 47.25
15.Secondary Outcome
Title Persistence at 12 Months for United Healthcare Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in United Healthcare cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 7203 2820 1184 72694 8100 18491 33868 25940 495 10490
Measure Type: Number
Unit of Measure: Percentage of participants
28.35 51.45 22.64 35.45 49.75 36.84 38.58 40.95 25.05 33.58
16.Secondary Outcome
Title Persistence at 3 Months for MarketScan Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in MarketScan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 81760 1918 29420
Measure Type: Number
Unit of Measure: Percentage of participants
73.47 83.39 68.90 76.89 82.82 81.58 78.72 82.12 69.08 73.05
17.Secondary Outcome
Title Persistence at 6 Months for MarketScan Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in MarketScan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 81760 1918 29420
Measure Type: Number
Unit of Measure: Percentage of participants
42.70 62.91 39.32 51.37 63.07 59.54 53.87 60.80 39.62 48.40
18.Secondary Outcome
Title Persistence at 12 Months for MarketScan Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in MarketScan cohort
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description:
Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
Overall Number of Participants Analyzed 22310 7708 5412 205213 24550 58769 104422 81760 1918 29420
Measure Type: Number
Unit of Measure: Percentage of participants
29.04 50.30 27.18 39.32 50.15 46.83 41.60 47.95 27.27 35.81
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and other (non-serious) adverse events were not of interest in this study and therefore were not collected or assessed as part of the study, in addition individual patient data is not available therefore adverse event data is not presented.
 
Arm/Group Title Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Hide Arm/Group Description Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication. Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication. Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication. Patients using Metformin as an oral and non-insulin injected glucose-lowering medication. Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication. Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication. Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication. Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication. Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication. Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
All-Cause Mortality
Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glitazones Linagliptin Meglitinides Metformin Saxagliptin Sitagliptin Sulfonylurea Other DPP-4I Alpha-Glucosidase Inhibitors GLP-I RA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02138097    
Other Study ID Numbers: 1218.161
First Submitted: May 13, 2014
First Posted: May 14, 2014
Results First Submitted: July 29, 2015
Results First Posted: October 6, 2015
Last Update Posted: October 6, 2015