| Primary | Change in HbA1c From Baseline to Week 24 | Change in HbA1c from baseline (Day 1) to Week 24 [Week 24 - Baseline]. | The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 24 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | | Least Squares Mean | Standard Error | percentage of total hemoglobin | | Day 1, Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.57± 0.104(-1.77 to -1.36)
- OG001-0.90± 0.110(-1.12 to -0.69)
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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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| Superiority of exenatide once weekly to BYETTA if the upper limit of the 2-sided 95% CI for treatment difference (exenatide once weekly minus BYETTA) is <0; noninferiority if this upper limit is <0.4%. Power: Assuming 15% dropout rate with 206 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in exenatide once weekly and a common standard deviation of 1.1%. | ANOVA | Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors. | <.0001 | | Least Squares Mean Difference | -0.67 | Standard Error of the Mean | 0.138 | 2-Sided | 95 | -0.94 | -0.39 | | | |
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| Secondary | Percentage of Subjects Achieving HbA1c Target of <7% | Percentages of subjects achieving HbA1c target value of <7% at Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal. | Posted | | Number | | percentage of subjects | | Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Percentage of Subjects Achieving HbA1c Target of <=6.5% | Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal. | Posted | | Number | | percentage of subjects | | Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Change in Fasting Plasma Glucose From Baseline to Week 24 | Change in fasting plasma glucose from baseline (Day 1) to Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Day 1, Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL | Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal. | Posted | | Number | | percentage of subjects | | Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Change in Body Weight From Baseline to Week 24 | Change in body weight from baseline (Day 1) to Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | | Least Squares Mean | Standard Error | kg | | Day 1, Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Change in Sitting Systolic Blood Pressure From Baseline to Week 24 | Change in systolic blood pressure from baseline (Day 1) to Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | | Least Squares Mean | Standard Error | mmHg | | Day 1, Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Change in Sitting Diastolic Blood Pressure From Baseline to Week 24 | Change in diastolic blood pressure from baseline (Day 1) to Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | | Least Squares Mean | Standard Error | mmHg | | Day 1, Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Change in Total Cholesterol From Baseline to Week 24 | Change in total cholesterol from baseline (Day 1) to Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Day 1, Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Change in High-density Lipoprotein (HDL) From Baseline to Week 24 | Change in HDL from baseline (Day 1) to Week 24. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Day 1, Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Ratio of Triglycerides at Week 24 to Baseline | Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline. | ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. | Posted | | Least Squares Mean | Standard Error | ratio | | Day 1, Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly | Subcutaneous injection of 2 mg exenatide, once a week | | OG001 | Exenatide Twice Daily | Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) |
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| Secondary | Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events | The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. | ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately. | Posted | | Mean | Standard Error | rate per subject-year | | Day 1 to Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly With SU | Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening | | OG001 | Exenatide Twice Daily With SU | Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening | | OG002 | Exenatide Once Weekly No SU | |
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| Secondary | Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events | The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia. | ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately. | Posted | | Mean | Standard Error | rate per subject-year | | Day 1 to Week 24 | | | | ID | Title | Description |
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| OG000 | Exenatide Once Weekly With SU | Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening | | OG001 | Exenatide Twice Daily With SU | Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening | | OG002 | Exenatide Once Weekly No SU | Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening | | OG003 | Exenatide Twice Daily No SU |
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