The effect of exenatide on gastric myoelectrical activity was assessed by electrogastrogram (EGG) using water load test (WLT). EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for distribution of average power in the bradygastria, normal, tachygastria and duodenal range during pre-WL and 10, 20 and 30 minutes post-WL after treatment with exenatide has been presented. The analysis was performed on Pharmacodynamic Population, which included all Par. who received at least one dose of study medication and had valid data.

Pharmacodynamic Population

The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for ratios of average power post- WLT/pre-WLT in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at 10, 20, and 30 minutes post-WL has been presented.

Pharmacodynamic Population

The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for dominant EGG frequencies including bradygastria, normal, tachygastria and duodenal at pre-WL and after treatment with exenatide at pre-WL and 10, 20, 30 minutes post-WL has been presented.

Pharmacodynamic Population

EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.

Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.

EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.

Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.

The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for average dominant frequency in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at Pre-WL and 10, 20, 30 minutes post-WL has been presented.

Pharmacodynamic Population

The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces nausea in Par. allowing the assessment of gastric myoelectrical activity during the episodes of nausea. The intensity of upper gastrointestinal symptom of nausea was measured using VAS ranging from 0 (no nausea) to 100 (severe nausea) immediately before (pre-WL) and 10, 20, 30 minutes post-WL. Individual Par. responses to VAS score scale has been presented.

Pharmacodynamic Population

Breath samples were collected to assess the time to half gastric emptying using gastric emptying breath test (GEBT) containing 13 Carbon (13C)-Spirulina pre-meal and post GEBT meal. The GEBT method was used to measure GE of solid food. The time to half gastric emptying for individual Par. has been presented.

Pharmacodynamic Population

The effect of exenatide on gastric emptying was be assessed by calculating the percent dose excreted of 13C in breath multiplied by 1000 (kPCD). Breath samples were collected at the indicated time points. Individual Par. data at pre-meal and 45, 90, 120, 150, 180 and 240 minutes post-meal has been presented.

Pharmacodynamic Population

GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: episodes (epi) of vomiting, epi of retching, nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe),to 5 (very severe). Individual Par. data has been presented. All Subjects Population was used which consisted of all Par. who received at least one dose of study medication.

All Subjects Population

The volume of water consumed by Par. at indicated time points after treatment with exenatide during EGG with WLT was determined. An EGG with WLT is a standardized test to induce gastric distention. Individual Par. data has been presented.

Pharmacodynamic Population

The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. The intensity of upper gastrointestinal symptoms was measured using VAS scores ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). Individual Par. responses to VAS has been presented.

Pharmacodynamic Population

SBP and DBP was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for SBP and DBP up to follow-up (up to 12 days) has been presented.

All Subjects Population

HR was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for HR up to follow-up (up to 12 days) has been presented.

All Subjects Population

Blood samples were collected for analysis of hematology parameters including basophils, eosinophil, lymphocytes, monocytes, platelet count, total neutrophils, and WBC. Individual Par. data at indicated time point has been presented.

All Subjects Population

Blood samples were collected for analysis of RBC count. Individual Par. data at indicated time point has been presented.

All Subjects Population

Blood samples were collected for analysis of hemoglobin level. Individual Par. data at indicated time point has been presented.

All Subjects Population

Blood samples were collected for analysis of hematocrit level. Individual Par. data at indicated time points has been presented.

All Subjects Population

Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and GGT. Individual Par. data at indicated time point has been presented.

All Subjects Population

Blood samples were collected for analysis of glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, and urea/BUN levels. Individual Par. data at indicated time point has been presented.

All Subjects Population

Blood samples were collected for analysis of clinical chemistry parameters including creatinine, direct bilirubin, total bilirubin, indirect bilirubin levels. Individual Par. data at indicated time points has been presented.

All Subjects Population

Estimated glomerular filtration rate was calculated using the "modification of diet in renal disease" (MDRD) formula by multiplying 175 with serum creatinine^-1.154 multiplied by age^-0.203 multiplied by 0.742 (if female) multiplied by 1.212 (if African American Par.). Individual Par. data at indicated time point has been presented.

All Subjects Population

Blood samples were collected for analysis of clinical chemistry parameters including total protein and albumin levels. Individual Par. data at indicated time point has been presented.

All Subjects Population

Samples were collected to analyze albumin level in urine. Individual Par. data at indicated time point has been collected.

All Subjects Population

Samples were collected to analyze concentration of creatinine in urine. Individual Par. at indicated time point has been presented at indicated time points.

All Subjects Population

Urine samples were collected to analyze presence of ketones, occult blood, glucose, nitrates and leukocyte esterase in urine. The dipstick test gives results in a semi-quantitative manner. NA represents data was not available due to lab data transfer error. Individual Par. data at indicated time point has been presented.

All Subjects Population

Samples were collected to analyze the presence of RBC and WBC in urine by microscopy. Individual Par. data at indicated time point has been presented. "NA" indicates data was not available as RBC and WBC count would only available if blood or protein were abnormal. The RBC and WBC values of "1" for participant 1 actually reflect 0-1.

All Subjects Population

Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Individual Par. data at indicated time point has been presented.

All Subjects Population

Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine.Individual Par. data at indicated time point has been presented.

All Subjects Population

An AE is any untoward medical occurrence in a clinical investigation Par. temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Number of Par. with AEs and SAEs have been presented.

All Subjects Population

GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT.

All Subjects Population.

EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with An WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

The VAS was used to measure the intensity of nausea analyzed on the basis of scores ranging from 0 (no nausea) to 100 (severe nausea). This analysis was planned but not performed for Part B as the study was terminated during Part A.

Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

The GEBT containing 13C-Spirulina was used to measure the time to half-gastric emptying. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

The rate of [13]C dose excreted in breath was assessed to study gastric empting using GEBT. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

EGG with WLT is a standardized test to induce gastric distention. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Vital signs included SBP, DBP and heart rate. This analysis was planned but not performed for Part B as the study was terminated during Part A.

All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils, WBC, RBC, hemoglobin and hematocrit levels. This analysis was planned but not performed for Part B as the study was terminated during Part A.

All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Clinical chemistry parameters included ALT, AST, GGT, glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, BUN, creatinine, direct bilirubin, total bilirubin, indirect bilirubin, glomerular filtration rate (MDRD Enzymatic level), total protein, and albumin level. This analysis was planned but not performed for Part B as the study was terminated during Part A.

All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Urinalysis included analysis of concentration of creatinine, presence of ketones and occult blood in urine (using dipstick test), presence RBC and WBC in urine (using microscopy), specific gravity and pH of urine. This analysis was planned but not performed for Part B as the study was terminated during Part A.

All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

An AE is any untoward medical occurrence in a clinical investigation Par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part B as the study was terminated during Part A.

All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). This analysis was planned but not performed for Part B as the study was terminated during Part A.

All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. This analysis was planned but not performed for Part B as the study was terminated during Part A.

All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.