Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, insulin, exenatide, Byetta, Amylin, Lilly
Brief summary
Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.
Interventions
DRUGexenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
DRUGany human insulin or analog insulin(s) given in any regimen by subcutaneous injection
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* are aged 18 or above * diagnosed with type 2 diabetes * have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes * have not previously been treated with either insulin or exenatide * are not simultaneously participating in another study which includes an investigational drug or procedure at study entry * have been fully informed and given their written consent for use of their data * have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. | Month 24 | The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time. Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study. Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following: Insulin: * Addition of a new medication for the treatment of type 2 diabetes * A change in the number of times insulin is administered per day * Discontinuation of any insulin initiated at baseline * Substitution of a human insulin for an analogue insulin or vice-versa. * Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change. Exenatide: * Addition of a new medication for the treatment of type 2 diabetes * Discontinuation of exenatide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for Discontinuation of Baseline Regimen | Baseline to Month 24 | Reasons for Discontinuation of Baseline Regimen |
| Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline | Baseline | Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher. |
| Older Age Associated With Treatment Choice at Baseline | Baseline | Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). |
| Disinhibited Eating Associated With Treatment Choice at Baseline | Baseline | Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). |
| Higher Random Glucose Associated With Treatment Choice at Baseline | 6 months prior to Baseline | Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). |
| Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline | 4 weeks prior to Baseline | Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). |
| Factors Associated With Treatment Change in Insulin Cohort | Baseline to Month 24 | Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort |
| Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | Baseline | Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). |
| Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline | Baseline | Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). |
| Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline | Baseline | Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m\^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m\^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment). |
| Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24 | Month 24 | Percentage of Patients Achieving HbA1c Concentration \<7.0% at Month 24. Only patients with baseline HbA1c \>= 7.0 % were included in this analysis |
| Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24 | Month 24 | Percentage of Patients Achieving HbA1c Concentration \<6.5% at Month 24. Note: Only patients with baseline HbA1c \>=6.5% were included in this analysis. |
| Changes in Weight From Baseline to Month 24 | Baseline, Month 24 | Changes in Weight From Baseline to Month 24 |
| Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months | Baseline to Month 24 | Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months |
| Incidence of Hypoglycemia Between Baseline and 24 Months | Baseline to Month 24 | Incidence of Hypoglycemia between Baseline and 24 Months |
| Factors Associated With Treatment Change in Exenatide BID Cohort | Baseline to Month 24 | Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998). |
| Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months | Baseline to Month 24 | Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months |
| Number of Contacts With Health Care Providers Between Baseline and 24 Months | Baseline to Month 24 | Number of contacts with Health Care Providers Between Baseline and 24 Months |
| Percentage of Patients Hospitalized Between Baseline and 24 Months | Baseline to Month 24 | Percentage of Patients Hospitalized Between Baseline and 24 Months |
| Changes in HbA1c From Baseline to Month 24 | Baseline, Month 24 | Changes in HbA1c From Baseline to Month 24 |
Countries
Denmark, France, Germany, Greece, Sweden
Participant flow
Recruitment details
This observational study was conducted at 322 study centers in 6 countries (Belgium, Denmark, France, Germany, Greece, Sweden). Date of first patient enrolled: 25 January 2008 Date of last patient completed: 01 December 2011
Pre-assignment details
2515 patients enrolled. 2388 patients in final analysis (22 not in either cohort), excluded: 92 had no investigator signature on summary page, 11 had no treatment start date, 2 had issues with their informed consent to release their data.
Participants by arm
| Arm | Count |
|---|---|
| Exenatide BID Daily dose ranging from 5-20 ug | 1,114 |
| Insulin Insulin at a dose selected by the HCP and patient | 1,274 |
| Total | 2,388 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 40 |
| Overall Study | Lost to Follow-up | 151 | 172 |
| Overall Study | Physician Decision | 32 | 22 |
| Overall Study | Sponsor decision | 2 | 3 |
| Overall Study | Withdrawal by Subject | 82 | 45 |
Baseline characteristics
| Characteristic | Insulin | Total | Exenatide BID |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 10.9 | 61.1 years STANDARD_DEVIATION 10.9 | 58.1 years STANDARD_DEVIATION 10.1 |
| Body Mass Index (BMI) | 29.7 kg/m2 STANDARD_DEVIATION 5.4 | 32.3 kg/m2 STANDARD_DEVIATION 6.6 | 35.3 kg/m2 STANDARD_DEVIATION 6.6 |
| Body Weight | 84.2 kg STANDARD_DEVIATION 17.6 | 92.1 kg STANDARD_DEVIATION 21.4 | 101.2 kg STANDARD_DEVIATION 21.8 |
| Concomitant Oral Anti-Diabetic Medication Combination of 2 OADs | 523 Number of Patients | 1075 Number of Patients | 552 Number of Patients |
| Concomitant Oral Anti-Diabetic Medication Combination of 3 OADs | 112 Number of Patients | 230 Number of Patients | 118 Number of Patients |
| Concomitant Oral Anti-Diabetic Medication Combination of 4 OADs | 9 Number of Patients | 20 Number of Patients | 11 Number of Patients |
| Concomitant Oral Anti-Diabetic Medication No OAD | 154 Number of Patients | 204 Number of Patients | 50 Number of Patients |
| Concomitant Oral Anti-Diabetic Medication Single OAD | 476 Number of Patients | 859 Number of Patients | 383 Number of Patients |
| Duration of Diabetes | 9.8 years STANDARD_DEVIATION 7.3 | 9.1 years STANDARD_DEVIATION 6.7 | 8.2 years STANDARD_DEVIATION 5.7 |
| Glycosylated hemoglobin (HbA1c) | 9.2 percentage of total hemoglobin STANDARD_DEVIATION 1.9 | 8.8 percentage of total hemoglobin STANDARD_DEVIATION 1.7 | 8.4 percentage of total hemoglobin STANDARD_DEVIATION 1.4 |
| Region of Enrollment Belgium | 163 participants | 279 participants | 116 participants |
| Region of Enrollment Denmark | 16 participants | 59 participants | 43 participants |
| Region of Enrollment France | 84 participants | 252 participants | 168 participants |
| Region of Enrollment Germany | 438 participants | 822 participants | 384 participants |
| Region of Enrollment Greece | 488 participants | 807 participants | 319 participants |
| Region of Enrollment Sweden | 85 participants | 169 participants | 84 participants |
| Sex: Female, Male Female | 541 Participants | 1057 Participants | 516 Participants |
| Sex: Female, Male Male | 733 Participants | 1331 Participants | 598 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time. Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study. Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following: Insulin: * Addition of a new medication for the treatment of type 2 diabetes * A change in the number of times insulin is administered per day * Discontinuation of any insulin initiated at baseline * Substitution of a human insulin for an analogue insulin or vice-versa. * Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change. Exenatide: * Addition of a new medication for the treatment of type 2 diabetes * Discontinuation of exenatide.
Time frame: Month 24
Population: All patients who provided consent to release information and who fulfil the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Exenatide BID | Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. | Estimate at 24 months | 53.9 probability (%) | 95% Confidence Interval 123 |
| Exenatide BID | Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. | Estimate at 12 months | 67.8 probability (%) | — |
| Insulin | Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. | Estimate at 24 months | 60.6 probability (%) | 95% Confidence Interval 123 |
| Insulin | Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. | Estimate at 12 months | 70.6 probability (%) | — |
Secondary
Changes in HbA1c From Baseline to Month 24
Changes in HbA1c From Baseline to Month 24
Time frame: Baseline, Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Changes in HbA1c From Baseline to Month 24 | -1.03 percentage of total hemoglobin | Standard Deviation 1.48 |
| Insulin | Changes in HbA1c From Baseline to Month 24 | -1.71 percentage of total hemoglobin | Standard Deviation 1.82 |
Secondary
Changes in Weight From Baseline to Month 24
Changes in Weight From Baseline to Month 24
Time frame: Baseline, Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Changes in Weight From Baseline to Month 24 | -3.22 kg | Standard Deviation 7.93 |
| Insulin | Changes in Weight From Baseline to Month 24 | 2.16 kg | Standard Deviation 6.24 |
Secondary
Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Time frame: Baseline
Population: All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exenatide BID | Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | Missing | 12 participants |
| Exenatide BID | Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | Yes | 910 participants |
| Exenatide BID | Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | No | 131 participants |
| Exenatide BID | Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | Unknown | 124 participants |
| Insulin | Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | No | 237 participants |
| Insulin | Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | Unknown | 172 participants |
| Insulin | Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | Missing | 1 participants |
| Insulin | Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline | Yes | 905 participants |
Comparison: Receipt of diet/exercise advice - Yes vs. Nop-value: 0.019395% CI: [1.13, 2.46]Regression, Logistic
Secondary
Disinhibited Eating Associated With Treatment Choice at Baseline
Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Time frame: Baseline
Population: All participants who provided consent to release information, fulfilled the study entry criteria, provided the specific data (DHP-18 subscale on disinhibited eating) and had a start date provided were included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Disinhibited Eating Associated With Treatment Choice at Baseline | 43.52 units on a scale | Standard Deviation 20.99 |
| Insulin | Disinhibited Eating Associated With Treatment Choice at Baseline | 34.38 units on a scale | Standard Deviation 20.33 |
Comparison: Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. Nop-value: 0.008395% CI: [1.01, 1.1]Regression, Logistic
Secondary
Factors Associated With Treatment Change in Exenatide BID Cohort
Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).
Time frame: Baseline to Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exenatide BID | Factors Associated With Treatment Change in Exenatide BID Cohort | Gastro intestinal symptoms: yes vs no at baseline | 1.463 hazard ratio |
| Exenatide BID | Factors Associated With Treatment Change in Exenatide BID Cohort | EQ-5D index value at baseline | 0.601 hazard ratio |
Comparison: GI symptoms: yes vs. no at baselinep-value: 0.02895% CI: [1.043, 2.053]Regression, Cox
Comparison: EQ-5D index value at baselinep-value: 0.00295% CI: [0.432, 0.834]Regression, Cox
Secondary
Factors Associated With Treatment Change in Insulin Cohort
Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort
Time frame: Baseline to Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exenatide BID | Factors Associated With Treatment Change in Insulin Cohort | HbA1c (%) at baseline | 1.118 hazard ratio |
| Exenatide BID | Factors Associated With Treatment Change in Insulin Cohort | DHP barriers to activity subscale at baseline | 0.960 hazard ratio |
| Exenatide BID | Factors Associated With Treatment Change in Insulin Cohort | Gastrointestinal symptoms: yes vs. no at baseline | 2.532 hazard ratio |
| Exenatide BID | Factors Associated With Treatment Change in Insulin Cohort | Insulin regimen: basal/bolus vs. long-acting only | 0.437 hazard ratio |
| Exenatide BID | Factors Associated With Treatment Change in Insulin Cohort | Insulin regimen: mixtures vs. long-acting only | 0.676 hazard ratio |
| Exenatide BID | Factors Associated With Treatment Change in Insulin Cohort | Insulin regimen: other vs. long-acting only | 0.549 hazard ratio |
| Exenatide BID | Factors Associated With Treatment Change in Insulin Cohort | Insulin regimen: short-acting only vs. long-actin | 2.164 hazard ratio |
Comparison: HbA1c (%) at baselinep-value: <0.000195% CI: [1.062, 1.177]Regression, Cox
Comparison: DHP barriers to activity subscale at baselinep-value: 0.00195% CI: [0.937, 0.985]Regression, Cox
Comparison: Gastrointestinal symptoms: yes vs. no at baselinep-value: <0.00195% CI: [1.698, 3.777]Regression, Cox
Comparison: Insulin regimen: basal/bolus vs. long-acting onlyp-value: <0.00195% CI: [0.303, 0.63]Regression, Cox
Comparison: Insulin regimen: mixtures vs. long-acting onlyp-value: 0.00395% CI: [0.523, 0.874]Regression, Cox
Comparison: Insulin regimen: other vs. long-acting onlyp-value: 0.30395% CI: [0.175, 1.718]Regression, Cox
Comparison: Insulin regimen: short-acting only vs. long-acting onlyp-value: <0.00195% CI: [1.681, 2.785]Regression, Cox
Secondary
Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Time frame: 4 weeks prior to Baseline
Population: All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline | 9.28 tests/week | Standard Deviation 7.98 |
| Insulin | Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline | 9.91 tests/week | Standard Deviation 8.58 |
Comparison: Blood glucose self-monitoring - 1 test/week morep-value: 0.010795% CI: [0.96, 0.99]Regression, Logistic
Secondary
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m\^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m\^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Time frame: Baseline
Population: All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline | 35.3 kg/m^2 | Standard Deviation 6.5 |
| Insulin | Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline | 29.7 kg/m^2 | Standard Deviation 5.4 |
Comparison: Body Mass Index (BMI) - 1kg/m² higherp-value: <0.000195% CI: [1.13, 1.19]Regression, Logistic
Secondary
Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.
Time frame: Baseline
Population: All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline | 8.4 percent of hemoglobin | Standard Deviation 1.4 |
| Insulin | Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline | 9.2 percent of hemoglobin | Standard Deviation 1.9 |
Comparison: Most recent HbA1c at baseline - 1% higher.p-value: <0.000195% CI: [0.69, 0.86]Regression, Logistic
Secondary
Higher Random Glucose Associated With Treatment Choice at Baseline
Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Time frame: 6 months prior to Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Higher Random Glucose Associated With Treatment Choice at Baseline | 10.37 mmol/L | Standard Deviation 3.13 |
| Insulin | Higher Random Glucose Associated With Treatment Choice at Baseline | 12.13 mmol/L | Standard Deviation 4.36 |
Comparison: Random blood glucose - 1 mmol/L higherp-value: 0.014195% CI: [0.9, 0.99]Regression, Logistic
Secondary
Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline
Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Time frame: Baseline
Population: All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline | 2.82 mmol/L | Standard Deviation 1.09 |
| Insulin | Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline | 3.00 mmol/L | Standard Deviation 1.01 |
Comparison: LDL cholesterol - 1 mmol/L higher at baselinep-value: 0.013895% CI: [0.72, 0.96]Regression, Logistic
Secondary
Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months
Time frame: Baseline to Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide BID | Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months | 29.4 percentage of patients |
| Insulin | Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months | 5.0 percentage of patients |
Secondary
Incidence of Hypoglycemia Between Baseline and 24 Months
Incidence of Hypoglycemia between Baseline and 24 Months
Time frame: Baseline to Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide BID | Incidence of Hypoglycemia Between Baseline and 24 Months | 17.5 percentage of patients |
| Insulin | Incidence of Hypoglycemia Between Baseline and 24 Months | 35.2 percentage of patients |
Secondary
Number of Contacts With Health Care Providers Between Baseline and 24 Months
Number of contacts with Health Care Providers Between Baseline and 24 Months
Time frame: Baseline to Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exenatide BID | Number of Contacts With Health Care Providers Between Baseline and 24 Months | Baseline to 24 months | 19.00 number of contacts | Standard Deviation 18.2 |
| Exenatide BID | Number of Contacts With Health Care Providers Between Baseline and 24 Months | Last 6 months prior to baseline | 7.17 number of contacts | Standard Deviation 6.92 |
| Insulin | Number of Contacts With Health Care Providers Between Baseline and 24 Months | Baseline to 24 months | 24.58 number of contacts | Standard Deviation 32.75 |
| Insulin | Number of Contacts With Health Care Providers Between Baseline and 24 Months | Last 6 months prior to baseline | 7.64 number of contacts | Standard Deviation 8.51 |
Secondary
Older Age Associated With Treatment Choice at Baseline
Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Time frame: Baseline
Population: All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide BID | Older Age Associated With Treatment Choice at Baseline | 58.1 years | Standard Deviation 10.1 |
| Insulin | Older Age Associated With Treatment Choice at Baseline | 63.7 years | Standard Deviation 10.9 |
Comparison: Age - 1 year olderp-value: <0.000195% CI: [0.95, 0.97]Regression, Logistic
Secondary
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24
Percentage of Patients Achieving HbA1c Concentration \<6.5% at Month 24. Note: Only patients with baseline HbA1c \>=6.5% were included in this analysis.
Time frame: Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide BID | Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24 | 12.5 percentage of patients |
| Insulin | Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24 | 10.7 percentage of patients |
Secondary
Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
Percentage of Patients Achieving HbA1c Concentration \<7.0% at Month 24. Only patients with baseline HbA1c \>= 7.0 % were included in this analysis
Time frame: Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide BID | Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24 | 26.9 percentage of patients |
| Insulin | Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24 | 28.5 percentage of patients |
Secondary
Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
Time frame: Baseline to Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exenatide BID | Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months | Last 6 months prior to baseline | 94.4 percentage of patients |
| Exenatide BID | Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months | Baseline to 24 months | 90.4 percentage of patients |
| Insulin | Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months | Last 6 months prior to baseline | 94.1 percentage of patients |
| Insulin | Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months | Baseline to 24 months | 92.3 percentage of patients |
Secondary
Percentage of Patients Hospitalized Between Baseline and 24 Months
Percentage of Patients Hospitalized Between Baseline and 24 Months
Time frame: Baseline to Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exenatide BID | Percentage of Patients Hospitalized Between Baseline and 24 Months | Last 6 months prior to baseline | 4.7 percentage of patients |
| Exenatide BID | Percentage of Patients Hospitalized Between Baseline and 24 Months | Baseline to 24 months | 4.3 percentage of patients |
| Insulin | Percentage of Patients Hospitalized Between Baseline and 24 Months | Last 6 months prior to baseline | 6.4 percentage of patients |
| Insulin | Percentage of Patients Hospitalized Between Baseline and 24 Months | Baseline to 24 months | 7.8 percentage of patients |
Secondary
Reasons for Discontinuation of Baseline Regimen
Reasons for Discontinuation of Baseline Regimen
Time frame: Baseline to Month 24
Population: Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exenatide BID | Reasons for Discontinuation of Baseline Regimen | Inadequate response | 170 number of patients |
| Exenatide BID | Reasons for Discontinuation of Baseline Regimen | Adverse event | 91 number of patients |
| Exenatide BID | Reasons for Discontinuation of Baseline Regimen | Patient decision | 69 number of patients |
| Exenatide BID | Reasons for Discontinuation of Baseline Regimen | Non compliance | 9 number of patients |
| Exenatide BID | Reasons for Discontinuation of Baseline Regimen | Cannot afford medication | 4 number of patients |
| Exenatide BID | Reasons for Discontinuation of Baseline Regimen | Other | 50 number of patients |
| Insulin | Reasons for Discontinuation of Baseline Regimen | Cannot afford medication | 1 number of patients |
| Insulin | Reasons for Discontinuation of Baseline Regimen | Inadequate response | 87 number of patients |
| Insulin | Reasons for Discontinuation of Baseline Regimen | Non compliance | 3 number of patients |
| Insulin | Reasons for Discontinuation of Baseline Regimen | Adverse event | 11 number of patients |
| Insulin | Reasons for Discontinuation of Baseline Regimen | Other | 38 number of patients |
| Insulin | Reasons for Discontinuation of Baseline Regimen | Patient decision | 15 number of patients |