Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes; exenatide; Byetta; basal insulin; Amylin; Lilly
Brief summary
Although the efficacy and safety profile of exenatide has been well established, few data exist on the real world results of exenatide treatment in specific populations and clinical settings. This study is intended to fill this gap through observing and collecting prospective data from a population of Italian patients initiating treatment with either exenatide or basal insulin formulations after failure to achieve glycemic control with oral antihyperglycemic agents (OHA). Observational studies represent noninterventional research; therefore, this study does not involve randomization of patients to particular comparator arms or therapies. The term noninterventional means that the healthcare providers decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice. Patients enrolled in this study are enrolling for the collection of their data on observations made during normal clinical practice.
Interventions
DRUGexenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
DRUGbasal insulin
subcutaneous injection, dosing according to physician's clinical judgment
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
1. Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c \> 7.0% 2. Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA 3. Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study 4. Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease 5. Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry 6. Have been fully informed and given their written consent for use of their data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12. | Baseline, Month 12 | Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fasting Blood Glucose From Baseline to Month 12 | Baseline, Month 12 | Changes in Fasting Blood Glucose From Baseline to Month 12 |
| Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12 | Baseline, Month 12 | Percentage of Patients with HbA1c Reduction from Baseline \>= 1.0% at Month 12 |
| Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12 | Month 12 | Percentage of Patients Achieving HbA1c Concentration \<=7.0% at Month 12 |
| Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12 | Month 12 | Percentage of Patients Achieving HbA1c Concentration \<6.5% at Month 12 |
| Changes in Weight From Baseline to Month 12 | Baseline, Month 12 | Changes in Weight From Baseline to Month 12 |
| Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12 | Baseline, Month 12 | Percentage of Patients Achieving a Weight Decrease \>=3% between Baseline and Month 12 |
| Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12 | Baseline, Month 12 | Percentage of Patients Achieving a Weight Decrease \>=5% between Baseline and Month 12 |
| Changes in Fasting Total Cholesterol Between Baseline and Month 12 | Baseline, Month 12 | Changes in Fasting Total Cholesterol Between Baseline and Month 12 |
| Changes in Fasting HDL Between Baseline and Month 12 | Baseline, Month 12 | Changes in Fasting HDL Between Baseline and Month 12 |
| Changes in Fasting LDL Between Baseline and Month 12 | Baseline, Month 12 | Changes in Fasting LDL Between Baseline and Month 12 |
| Changes in HbA1c From Baseline to Month 12 | Baseline, Month 12 | Changes in HbA1c from Baseline to Month 12 |
| Changes in Diastolic Blood Pressure Between Baseline and Month 12 | Baseline, Month 12 | Changes in Diastolic Blood Pressure Between Baseline and Month 12 |
| Changes in Systolic Blood Pressure Between Baseline and Month 12 | Baseline, Month 12 | Changes in Systolic Blood Pressure Between Baseline and Month 12 |
| Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12 | Baseline to Month 12 | Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12. All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected. |
| Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | baseline | Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. |
| Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline | baseline | Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%). |
| Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline | baseline | The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis. |
| Factor of Older Age Associated With Treatment Choice at Baseline | baseline | Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years. |
| Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline | baseline | Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m\^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m\^2. |
| Factor of Greater Height Associated With Treatment Choice at Baseline | baseline | Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) . |
| Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | baseline | Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL). |
| Changes in Fasting Triglycerides Between Baseline and Month 12 | Baseline, Month 12 | Changes in Fasting Triglycerides Between Baseline and Month 12 |
Countries
Italy
Participant flow
Pre-assignment details
Six patients were not assigned to any cohort because the type of treatment taken was not reported.
Participants by arm
| Arm | Count |
|---|---|
| Exenatide The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day | 444 |
| Basal Insulin The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment | 438 |
| Total | 882 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Death | 2 | 3 |
| Overall Study | entry criteria not met | 4 | 3 |
| Overall Study | lack of compliance | 5 | 2 |
| Overall Study | lack of glycemic control | 2 | 1 |
| Overall Study | Lost to Follow-up | 18 | 34 |
| Overall Study | Withdrawal by Subject | 35 | 23 |
Baseline characteristics
| Characteristic | Exenatide | Basal Insulin | Total |
|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 9.65 | 65.9 years STANDARD_DEVIATION 9.62 | 62.5 years STANDARD_DEVIATION 10.19 |
| Glycosylated hemoglobin (HbA1c) | 8.7 percent STANDARD_DEVIATION 1.34 | 9.2 percent STANDARD_DEVIATION 1.4 | 8.9 percent STANDARD_DEVIATION 1.39 |
| Sex: Female, Male Female | 198 Participants | 191 Participants | 389 Participants |
| Sex: Female, Male Male | 246 Participants | 247 Participants | 493 Participants |
| Weight | 97.5 kg STANDARD_DEVIATION 21.39 | 79.5 kg STANDARD_DEVIATION 15.82 | 88.6 kg STANDARD_DEVIATION 20.91 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 444 | 9 / 438 |
| serious Total, serious adverse events | 11 / 444 | 10 / 438 |
Outcome results
Primary
Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.
Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12. | 35.0 percentage of patients |
| Basal Insulin | Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12. | 15.8 percentage of patients |
Secondary
Changes in Diastolic Blood Pressure Between Baseline and Month 12
Changes in Diastolic Blood Pressure Between Baseline and Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in Diastolic Blood Pressure Between Baseline and Month 12 | -2.4 mmHg | Standard Deviation 10.4 |
| Basal Insulin | Changes in Diastolic Blood Pressure Between Baseline and Month 12 | 0.2 mmHg | Standard Deviation 10.2 |
Secondary
Changes in Fasting Blood Glucose From Baseline to Month 12
Changes in Fasting Blood Glucose From Baseline to Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in Fasting Blood Glucose From Baseline to Month 12 | -26.7 mg/dL | Standard Deviation 57.05 |
| Basal Insulin | Changes in Fasting Blood Glucose From Baseline to Month 12 | -51.4 mg/dL | Standard Deviation 64.53 |
Secondary
Changes in Fasting HDL Between Baseline and Month 12
Changes in Fasting HDL Between Baseline and Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in Fasting HDL Between Baseline and Month 12 | 1.3 mg/dL | Standard Deviation 10.12 |
| Basal Insulin | Changes in Fasting HDL Between Baseline and Month 12 | 0.2 mg/dL | Standard Deviation 10.18 |
Secondary
Changes in Fasting LDL Between Baseline and Month 12
Changes in Fasting LDL Between Baseline and Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in Fasting LDL Between Baseline and Month 12 | -4.6 mg/dL | Standard Deviation 30.79 |
| Basal Insulin | Changes in Fasting LDL Between Baseline and Month 12 | -4.5 mg/dL | Standard Deviation 38.35 |
Secondary
Changes in Fasting Total Cholesterol Between Baseline and Month 12
Changes in Fasting Total Cholesterol Between Baseline and Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in Fasting Total Cholesterol Between Baseline and Month 12 | -6.0 mg/dL | Standard Deviation 36.22 |
| Basal Insulin | Changes in Fasting Total Cholesterol Between Baseline and Month 12 | -7.5 mg/dL | Standard Deviation 43.58 |
Secondary
Changes in Fasting Triglycerides Between Baseline and Month 12
Changes in Fasting Triglycerides Between Baseline and Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in Fasting Triglycerides Between Baseline and Month 12 | -16.5 mg/dL | Standard Deviation 115.27 |
| Basal Insulin | Changes in Fasting Triglycerides Between Baseline and Month 12 | -30.2 mg/dL | Standard Deviation 108.15 |
Secondary
Changes in HbA1c From Baseline to Month 12
Changes in HbA1c from Baseline to Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in HbA1c From Baseline to Month 12 | -1.1 percent | Standard Deviation 1.4 |
| Basal Insulin | Changes in HbA1c From Baseline to Month 12 | -1.4 percent | Standard Deviation 1.49 |
Secondary
Changes in Systolic Blood Pressure Between Baseline and Month 12
Changes in Systolic Blood Pressure Between Baseline and Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in Systolic Blood Pressure Between Baseline and Month 12 | -4.6 mmHg | Standard Deviation 18.74 |
| Basal Insulin | Changes in Systolic Blood Pressure Between Baseline and Month 12 | -1.0 mmHg | Standard Deviation 17.56 |
Secondary
Changes in Weight From Baseline to Month 12
Changes in Weight From Baseline to Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Changes in Weight From Baseline to Month 12 | -3.9 kg | Standard Deviation 5.92 |
| Basal Insulin | Changes in Weight From Baseline to Month 12 | 0.2 kg | Standard Deviation 4.78 |
Secondary
Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline
Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).
Time frame: baseline
Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS=444, however 1 patient in the exenatide arm was missing data for the most recent HbA1c at baseline so n=443.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline | 8.7 Percentage of normal | Standard Deviation 1.34 |
| Basal Insulin | Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline | 9.2 Percentage of normal | Standard Deviation 1.4 |
Comparison: Logistic regression analysis was used to determine if Baseline HbA1c was 1% more, was it associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: <0.00195% CI: [0.6, 0.78]Regression, Logistic
Secondary
Factor of Greater Height Associated With Treatment Choice at Baseline
Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .
Time frame: baseline
Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS for basal insulin arm=438 but one patient did not provide height data so n=437.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Factor of Greater Height Associated With Treatment Choice at Baseline | 165.8 cm | Standard Deviation 9.56 |
| Basal Insulin | Factor of Greater Height Associated With Treatment Choice at Baseline | 164.4 cm | Standard Deviation 9.1 |
Comparison: Logistic regression analysis was used to determine if greater height (1 cm higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: 0.02695% CI: [1, 1.05]Regression, Logistic
Secondary
Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m\^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m\^2.
Time frame: baseline
Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS for basal insulin arm=438 but one patient did not have data in this arm so n=437.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline | 35.4 kg/m^2 | Standard Deviation 6.83 |
| Basal Insulin | Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline | 29.4 kg/m^2 | Standard Deviation 5.12 |
Comparison: Logistic regression analysis was used to determine if higher BMI (1 kg/m\^2 higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: <0.00195% CI: [1.15, 1.23]Regression, Logistic
Secondary
Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline
The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.
Time frame: baseline
Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline | 9.0 years | Standard Deviation 7.03 |
| Basal Insulin | Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline | 12.4 years | Standard Deviation 8.29 |
Comparison: Logistic regression analysis was used to determine if longer duration of diabetes was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: 0.05595% CI: [0.96, 1]Regression, Logistic
Secondary
Factor of Older Age Associated With Treatment Choice at Baseline
Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.
Time frame: baseline
Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Factor of Older Age Associated With Treatment Choice at Baseline | 59.2 years | Standard Deviation 9.65 |
| Basal Insulin | Factor of Older Age Associated With Treatment Choice at Baseline | 65.9 years | Standard Deviation 9.62 |
Comparison: Logistic regression analysis was used to determine if older age (1 year older), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: <0.00195% CI: [0.95, 0.99]Regression, Logistic
Secondary
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline
Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.
Time frame: baseline
Population: All patients consented to release information; fulfilled study entry criteria. Analyses conducted on baseline arm assignment, irrespective of later treatment changes. Only those assigned to an arm were included. Missing values for numeric covariates replaced with means; categorical ones, with modes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exenatide | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Male Gender | 246 participants |
| Exenatide | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Female Gender | 198 participants |
| Exenatide | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Medical conditions present | 371 participants |
| Exenatide | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | No medical conditions | 73 participants |
| Exenatide | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Previous gastrointestinal symptoms present | 8 participants |
| Exenatide | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | No gastrointestinal symptoms | 436 participants |
| Basal Insulin | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Previous gastrointestinal symptoms present | 11 participants |
| Basal Insulin | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Male Gender | 247 participants |
| Basal Insulin | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | No medical conditions | 75 participants |
| Basal Insulin | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Female Gender | 191 participants |
| Basal Insulin | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | No gastrointestinal symptoms | 427 participants |
| Basal Insulin | Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Medical conditions present | 363 participants |
Comparison: Logistic regression analysis was used to determine if Baseline Gender (Male vs. Female), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: 0.83195% CI: [0.62, 1.46]Regression, Logistic
Comparison: Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.p-value: 0.55495% CI: [0.74, 1.76]Regression, Logistic
Comparison: Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.p-value: 0.71495% CI: [0.43, 3.42]Regression, Logistic
Secondary
Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline
Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).
Time frame: baseline
Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FASS=444 and 438 in each arm respectively but the number of patients with creatinine and fasting lipids data at baseline varied. N is presented with each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exenatide | Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | Creatinine (N=324, 333) | 0.9 mg/dL | Standard Deviation 0.24 |
| Exenatide | Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | HDL (N=335, 326) | 44.7 mg/dL | Standard Deviation 12.82 |
| Exenatide | Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | Total Cholesterol (N=368, 355) | 181.1 mg/dL | Standard Deviation 40 |
| Exenatide | Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | Triglycerides (N=364, 360) | 177.5 mg/dL | Standard Deviation 112.57 |
| Basal Insulin | Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | Triglycerides (N=364, 360) | 173.6 mg/dL | Standard Deviation 104.24 |
| Basal Insulin | Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | Creatinine (N=324, 333) | 1.0 mg/dL | Standard Deviation 0.39 |
| Basal Insulin | Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | Total Cholesterol (N=368, 355) | 182.7 mg/dL | Standard Deviation 41.79 |
| Basal Insulin | Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline | HDL (N=335, 326) | 46.9 mg/dL | Standard Deviation 12.31 |
Comparison: Logistic regression analysis was used to determine if higher baseline creatinine (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: 0.00795% CI: [0.18, 0.77]Regression, Logistic
Comparison: Logistic regression analysis was used to determine if higher baseline fasting HDL cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: 0.09495% CI: [0.97, 1]Regression, Logistic
Comparison: Logistic regression analysis was used to determine if higher baseline fasting total cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: 0.25995% CI: [1, 1.01]Regression, Logistic
Comparison: Logistic regression analysis was used to determine if higher baseline fasting triglycerides (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.p-value: 0.12395% CI: [1, 1]Regression, Logistic
Secondary
Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12
Percentage of Patients Achieving a Weight Decrease \>=3% between Baseline and Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12 | 43.0 percentage of patients |
| Basal Insulin | Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12 | 17.6 percentage of patients |
Secondary
Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12
Percentage of Patients Achieving a Weight Decrease \>=5% between Baseline and Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12 | 29.7 percentage of patients |
| Basal Insulin | Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12 | 10.7 percentage of patients |
Secondary
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12
Percentage of Patients Achieving HbA1c Concentration \<6.5% at Month 12
Time frame: Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12 | 13.1 percentage of patients |
| Basal Insulin | Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12 | 4.9 percentage of patients |
Secondary
Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12
Percentage of Patients Achieving HbA1c Concentration \<=7.0% at Month 12
Time frame: Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12 | 39.0 percentage of patients |
| Basal Insulin | Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12 | 22.2 percentage of patients |
Secondary
Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12
Percentage of Patients with HbA1c Reduction from Baseline \>= 1.0% at Month 12
Time frame: Baseline, Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12 | 49.4 percentage of patients |
| Basal Insulin | Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12 | 51.1 percentage of patients |
Secondary
Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12
Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12. All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.
Time frame: Baseline to Month 12
Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12 | 3.6 percentage of patients |
| Basal Insulin | Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12 | 8.2 percentage of patients |