| Primary | Change in Body Weight | Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0) | Intent to Treat population | Posted | | Least Squares Mean | Standard Error | kg | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| | | Title | Denominators | Categories |
|---|
| Baseline (Week 0) | | | Title | Measurements |
|---|
| - OG000109.48± 2.70
- OG001107.64± 2.61
|
| | Change at Endpoint (Week 24) | | |
| | 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 |
|---|
| Analysis pertains to change at endpoint (Week 24) | Mixed Model Repeated Measures ANCOVA | | <0.0001 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| Secondary | Change in Body Mass Index (BMI) | Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0) | Intent to Treat population | Posted | | Least Squares Mean | Standard Error | kg/m^2 | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Change in Waist-to-hip Ratio | Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint. | Intent to Treat population | Posted | | Least Squares Mean | Standard Error | Ratio | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Percentage of Patients Experiencing >=5% Weight Loss | Percentage of exenatide and placebo treated patients experiencing >=5% weight loss after 24 weeks of treatment (i.e., [weight at week 0 minus weight at week 24] divided by weight at week 0 times 100% >=5%) | Intent to Treat population; Last Observation Carried Forward | Posted | | Number | | percentage of patients | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Change in Total Cholesterol | Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0) | Intent to Treat population; Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | mmol/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Change in High Density Lipoprotein (HDL) Cholesterol | Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0) | Intent to Treat population; Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | mmol/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) | Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0) | Intent to Treat population; Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | Ratio | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Change in Low Density Lipoprotein (LDL) Cholesterol | Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0) | Intent to Treat population; Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | mmol/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Change in Fasting Serum Glucose | Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0) | Intent to Treat population | Posted | | Least Squares Mean | Standard Error | mmol/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0) | Intent to Treat population; Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | (mmol*hr)/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed) | Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function. | Intent to Treat population; Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | Ratio | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed) | Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity. | Intent to Treat population; Last Observation Carried Forward | Posted | | Least Squares Mean | Standard Error | Ratio | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis | Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24 | Intent to Treat population | Posted | | Number | | Participants | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) | Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24 | Intent to Treat population | Posted | | Number | | Participants | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Change in High Sensitivity C-reactive Protein (hsCRP) | Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0) | Intent to Treat population | Posted | | Least Squares Mean | Standard Error | pmol/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |
| Secondary | Change in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0) | Intent to Treat population | Posted | | Least Squares Mean | Standard Error | percent | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A (Exenatide) | exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | | OG001 | Group B (Placebo) | placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP |
| |