| Primary | Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) | Composite endpoint evaluating effect of treatment on glycemic control and weight | Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders. | Posted | | Number | | percentage of participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome | Regression, Logistic | | <0.001 | | Odds Ratio (OR) | 4.71 | | | | 95 | 2.62 | 8.46 | | | | No | Superiority or Other | | |
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| Secondary | Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg | Composite endpoint evaluating effect of treatment on glycemic control and weight | Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders. | Posted | | Number | | Percentage of participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Fasting Serum Glucose | Change in fasting serum glucose from baseline (week 0) to endpoint (week 26) | Full Analysis Set, Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | mmol/L | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Percent of Patients Achieving HbA1c ≤ 7.4% | Percent of patients achieving specified HbA1c target at endpoint | Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis. | Posted | | Number | | Percentage of participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Percent of Patients Achieving HbA1c < 7% | Percent of patients achieving specified HbA1c target at endpoint | Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis. | Posted | | Number | | Percentage of participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Percent of Patients Achieving HbA1c < 6.5% | Percent of patients achieving specified HbA1c target at endpoint | Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis. | Posted | | Number | | Percentage of participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in 7 Point Self Monitored Blood Glucose Profile | Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day | Full Analysis Set, Last Observation Carried Forward | Posted | | Mean | Standard Deviation | mmol/L | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Body Mass Index (BMI) | Change in BMI from baseline to endpoint | | Posted | | Least Squares Mean | Standard Error | kg/m^2 | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Waist Circumference | Change in waist circumference from baseline to endpoint | | Posted | | Least Squares Mean | Standard Error | cm | | 26 Weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Waist-to-hip Ratio | Change in waist-to-hip ratio from baseline to endpoint | | Posted | | Least Squares Mean | Standard Error | Ratio | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Body Weight | Change in body weight from baseline to endpoint | | Posted | | Least Squares Mean | Standard Error | kg | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Percent Change in Body Weight | Percent change in baseline body weight at endpoint | | Posted | | Least Squares Mean | Standard Error | Percentage | | 26 Weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Percent of Patients Achieving 5% Weight Loss | Percent of patients who lost at least 5% of baseline body weight at endpoint | Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis. | Posted | | Number | | Percentage of participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Percent of Patients Achieving 10% Weight Loss | Percent of patients who lost at least 10% of baseline body weight at endpoint | Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis. | Posted | | Number | | Percentage of participants | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Systolic Blood Pressure | Change in systolic blood pressure from baseline to endpoint | | Posted | | Least Squares Mean | Standard Error | mmHg | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Diastolic Blood Pressure | Change in diastolic blood pressure from baseline to endpoint | | Posted | | Least Squares Mean | Standard Error | mmHg | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
| |
| Secondary | Change in Fasting Serum Total Cholesterol (TC) | Change in TC from baseline to endpoint | Full Analysis Set, Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | mmol/L | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in High Density Lipoprotein (HDL) Cholesterol | Change in HDL cholesterol from baseline to endpoint | Full Analysis Set, Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | mmol/L | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in TC to HDL Cholesterol Ratio | Change in TC to HDL cholesterol ratio from baseline to endpoint | Full Analysis Set, Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | Ratio | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Fasting Serum Triglycerides | Change in fasting serum triglycerides from baseline to endpoint | Full Analysis Set, Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | mmol/L | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Low Density Lipoprotein (LDL) Cholesterol | Change in LDL cholesterol from baseline to endpoint | Full Analysis Set, Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | mmol/L | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Change in Apolipoprotein-B | Change in apolipoprotein-B from baseline to endpoint | Full Analysis Set, Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | g/L | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Incidence of Hypoglycemic Episodes | Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study | | Posted | | Number | | percent | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
| |
| Secondary | Incidence of Nocturnal Hypoglycemic Episodes | Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study | | Posted | | Number | | percent | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Incidence of Severe Hypoglycemic Episodes | Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study | | Posted | | Number | | percent | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Hypoglycemic Rate Per 30 Days | Number of hypoglycemic episodes per patient adjusted per 30 days | | Posted | | Median | Inter-Quartile Range | Number of episodes per 30 days | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Nocturnal Hypoglycemic Rate Per 30 Days | Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days | | Posted | | Median | Inter-Quartile Range | Number of episodes per 30 days | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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| Secondary | Severe Hypoglycemic Rate Per 30 Days | Number of severe hypoglycemic episodes per patient adjusted per 30 days | | Posted | | Median | Full Range | Number of episodes per 30 days | | 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Exenatide | 5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks | | OG001 | Insulin Glargine | dosing based on treat to target protocol |
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