| Outcome Measures: |
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., Baseline, Month 12 | Secondary: Changes in HbA1c From Baseline to Month 12, Changes in HbA1c from Baseline to Month 12, Baseline, Month 12|Changes in Fasting Blood Glucose From Baseline to Month 12, Changes in Fasting Blood Glucose From Baseline to Month 12, Baseline, Month 12|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, Baseline, Month 12|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12, Percentage of Patients Achieving HbA1c Concentration \<=7.0% at Month 12, Month 12|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12, Percentage of Patients Achieving HbA1c Concentration \<6.5% at Month 12, Month 12|Changes in Weight From Baseline to Month 12, Changes in Weight From Baseline to 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 \>=3% between Baseline and Month 12, Baseline, Month 12|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, Baseline, Month 12|Changes in Fasting Total Cholesterol Between Baseline and Month 12, Changes in Fasting Total Cholesterol Between Baseline and Month 12, Baseline, Month 12|Changes in Fasting HDL Between Baseline and Month 12, Changes in Fasting HDL Between Baseline and Month 12, Baseline, Month 12|Changes in Fasting LDL Between Baseline and Month 12, Changes in Fasting LDL Between Baseline and Month 12, Baseline, Month 12|Changes in Fasting Triglycerides Between Baseline and Month 12, Changes in Fasting Triglycerides Between Baseline and Month 12, Baseline, Month 12|Changes in Diastolic Blood Pressure Between Baseline and Month 12, Changes in Diastolic Blood Pressure Between Baseline and Month 12, Baseline, Month 12|Changes in Systolic Blood Pressure Between Baseline and Month 12, Changes in Systolic Blood Pressure Between Baseline and Month 12, Baseline, Month 12|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., Baseline to Month 12|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., baseline|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 (%)., baseline|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., baseline|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., baseline|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., baseline|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) ., baseline|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)., baseline
|
| Locations: |
Research site, Acquaviva delle Fonti, Italy|Research site, Anzio, Italy|Research site, Bassano del Grappa, Italy|Research site, Bologna, Italy|Research site, Brindisi, Italy|Research site, Cagliari, Italy|Research site, Campi Salentina, Italy|Research site, Casarano, Italy|Research site, Caserta, Italy|Research site, Cesena, Italy|Research site, Chieri, Italy|Research site, Cisternino, Italy|Research site, Copertino, Italy|Research site, Cremona, Italy|Research site, Distretto Vittoria, Italy|Research site, Fermo, Italy|Research site, Ferrara, Italy|Research site, Fidenza, Italy|Research site, Firenze, Italy|Research site, Forlì, Italy|Research site, Genova, Italy|Research site, Germaneto, Italy|Research site, Lecce, Italy|Research site, Livorno, Italy|Research site, Lucca, Italy|Research site, Manfredonia (Le), Italy|Research site, Mariano Comense, Italy|Research site, Messina, Italy|Research site, Milano, Italy|Research site, Monza, Italy|Research site, Napoli, Italy|Research site, Novara, Italy|Research site, Olbia, Italy|Research site, Palermo, Italy|Research site, Palmi, Italy|Research site, Parma, Italy|Research site, Pavia, Italy|Research site, Pisa, Italy|Research site, Potenza, Italy|Research site, Rimini, Italy|Research site, Roma, Italy|Research site, Rossano Scalo, Italy|Research site, Salerno, Italy|Research site, San Giovanni Rotondo, Italy|Research site, Schio, Italy|Research site, Sesto San Giovanni, Italy|Research site, Sienna, Italy|Research site, Treviso, Italy|Research site, Trieste, Italy|Research site, Varese, Italy
|
