An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02793154
• Collaborator: Wake Forrest Baptist Health (Other)
• Enrollment: 4
• Locations: 2
• Arms: 3
• Actual Duration (Months): 5.6
• Patients Per Site: 2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare the effect of albiglutide and exenatide on gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual analogue scale [VAS]) in subjects with type 2 diabetes mellitus (T2DM). The study is divided in two parts. Part A will characterize the GMA, GE and nausea response to exenatide and confirm exenatide as a positive control for Part B. Part B will compare the effects of albiglutide and exenatide on GMA, GE and nausea.

Part A is a single arm, open-label design and all subjects will receive 10 microgram (mcg) subcutaneous exenatide twice daily for 5 days. This part will comprise 3 study periods: a 3-week screening/wash-out, 5-day treatment, and follow-up (within 7 days after the last dose of exenatide). The total duration of a subject's participation in Part A will be approximately 5 weeks. Once Part A is complete, data will be reviewed and a decision to progress to Part B will be made.

In Part B, subjects will be randomized 1:1 to receive either albiglutide (starting dose of 30 milligrams [mg] once weekly for 4 weeks, followed by 50 mg once weekly for 4 weeks) or exenatide (starting dose of 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 4 weeks). The total duration of a subject's participation in the study will be approximately 15 weeks.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Exenatide; Drug: Albiglutide	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Active-Controlled, Parallel-Group, Exploratory Study on the Effects of Repeated Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus
• Actual Study Start Date: Sep 26, 2016
• Actual Primary Completion Date: Mar 16, 2017
• Actual Study Completion Date: Mar 16, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: Exenatide Part A is a single arm design and all subjects will receive 10 mcg subcutaneous injection (SC) of exenatide twice daily for 5 days	Drug: Exenatide; Supplied as SC injection containing 250 mcg/mL of exenatide, provided in the following dose regimens: Part A: 10 mcg taken twice daily for 5 days; Part B: 5 mcg twice daily taken for 4 weeks followed by uptitration to 10 mcg for 4 weeks In both parts, it will be administered within 60-minute period before morning and evening meals (or before 2 meals with approximate >=6 hours apart); Other Names: Byetta
Experimental: Part B: Albiglutide In Part B, half of the subjects will be randomized to receive albiglutide: On Day 1: Once weekly SC injection at 30 mg for 4 weeks From Week 5, Day 1: Dose will be increased to 50 mg once weekly SC injection for 4 weeks	Drug: Albiglutide; Part B: Albiglutide will be supplied as follows:30 mg SC injection pen containing 40.3 mg lyophilized albiglutide and 0.65 mL; 50 mg SC injection pen contains 67 mg lyophilized albiglutide and 0.65 mL water; Starting dose will be 30 mg weekly for 4 weeks and then uptitrated to 50 mg weekly for 4 weeks; Administered as a single SC injection once a week in the morning; Other Names: Tanzeum in US
Active Comparator: Part B: Exenatide In Part B, half of the subjects will be randomized to receive exenatide: On Day 1: Twice daily SC injection at 5 mcg for 4 weeks. From Week 5, Day 1: Dose will be uptitrated to 10 mcg twice daily SC injection for 4 weeks	Drug: Exenatide; Supplied as SC injection containing 250 mcg/mL of exenatide, provided in the following dose regimens: Part A: 10 mcg taken twice daily for 5 days; Part B: 5 mcg twice daily taken for 4 weeks followed by uptitration to 10 mcg for 4 weeks In both parts, it will be administered within 60-minute period before morning and evening meals (or before 2 meals with approximate >=6 hours apart); Other Names: Byetta

Outcome Measures

Primary Outcome Measures

1. Part A: Distribution of Average Power by Frequency Region [Up to Day 4]

   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.

2. Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region [Up to Day 4]

   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.

3. Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal [Up to Day 4]

   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.

4. Part A: Number of Par. With Shifts in Gastric Rhythm Status [Up to 12 days]

   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.

5. Part A: Number Par. by Gastric Rhythm Status [Up to 12 days]

   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.

6. Part A: Average Dominant Frequency [Up to Day 4]

   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.

7. Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score [Day 4]

   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.

8. Part A: Time to Half-gastric Emptying [Up to Day 5]

   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.

9. Part A: Rate of [13]C Dose Excreted in Breath [Day 5]

   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.

10. Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score [Up to Day 5]

    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.

11. Part A: The Volume of Water Ingested During EGG [Up to Day 4]

    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.

12. Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score [Day 4]

    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.

13. Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety [Up to 12 days]

    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.

14. Part A: Assessment of Heart Rate (HR) as a Measure of Safety [Up to 12 days]

    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.

15. Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points [Day 5]

    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.

16. Part A: Red Blood Cell (RBC) Count at Indicated Time Points [Day 5]

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

17. Part A: Hemoglobin Level at Indicated Time Points [Day 5]

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

18. Part A: Hematocrit Level at Indicated Time Points [Day 5]

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

19. Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points [Day 5]

    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.

20. Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels [Day 5]

    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.

21. Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points [Day 5]

    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.

22. Part A: Estimated Glomerular Filtration Rate at Indicated Time Points [Day 5]

    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.

23. Part A: Total Protein, Albumin Levels at Indicated Time Points [Day 5]

    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.

24. Part A: Albumin Level in Urine at Indicated Time Points [Day 5]

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

25. Part A: Concentration of Creatinine in Urine at Indicated Time Points [Day 5]

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

26. Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points [Day 5]

    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.

27. Part A: Presence RBC and WBC in Urine Assessed by Microscopy [Day 5]

    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.

28. Part A: Specific Gravity of Urine at Indicated Time Points [Day 5]

    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.

29. Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points [Day 5]

    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.

30. Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs) [Up to 12 days]

    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.

31. Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD [Up to 12 days]

    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.

32. Part B: Distribution of Average Power by Frequency Region [Up to 8 weeks]

    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.

33. Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region [Up to 8 weeks]

    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.

34. Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal [Up to 8 weeks]

    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.

35. Part B: Assessment of Nausea by VAS Score [Up to 8 weeks]

    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.

Secondary Outcome Measures

1. Part B: Time to Half-gastric Emptying [Up to 8 weeks]

   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.

2. Part B: Rate of [13]C Dose Excreted in Breath [Up to 8 weeks]

   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.

3. Part B: The Volume of Water Ingested During EGG [Up to 8 weeks]

   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.

4. Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score [Up to 8 weeks]

   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.

5. Part B: Number of Par. With Abnormal Values for Vital Signs [Up to 12 weeks]

   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.

6. Part B: Number of Par. With Abnormal Values for Hematology Parameters [Up to 8 weeks]

   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.

7. Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters [Up to 8 weeks]

   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.

8. Part B: Number of Par. With Abnormal Values for Urinalysis [Up to 8 weeks]

   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.

9. Part B: Number of Par. With AEs and SAEs [Up to 12 weeks]

   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.

10. Part B: Assessment of GCSI-DD Score [Up to 8 weeks]

    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.

11. Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD [Up to 12 weeks]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, aged between 18 and 60 years of age at the time of signing the informed consent.

• Type 2 diabetes mellitus diagnosed at least 6 months prior to screening.

• Subjects treated with diet and exercise alone or stable dose of single oral antihyperglycemic medication (OAM) of metformin, sulfonylurea (except chlorpropamide), sodium glucose co-transporter 2-inhibitor, or meglitinide for at least 2 months prior to screening

• Glycated hemoglobin A1C (HbA1c) >6.5% and <=9.0% at screening. If the first HbA1c value does not meet eligibility criterion, the HbA1c may be rechecked once during screening. If the average of these determinations meets the criterion, the subject is eligible.

• Fasting plasma glucose (FPG) <=210 mg/deciliter (dL; central lab) at screening. If the first FPG value does not meet eligibility criterion, the FPG may be rechecked once during screening.

• Patient assessment of upper GI symptom severity index at screening:

Overall score <=20 (if score is >=21 and <=25, subjects can be re-evaluated 2 weeks later) Total score of items 1-9 is <=9 Score from any of single item <=2

• Body mass index (BMI) >20 kilograms (kg)/meter (m)^{2 and <35 kg/m}2 and a stable weight (no more than 5% reported change within 3 months prior to screening).

• A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test for females of reproductive potential [FRP] only), not breastfeeding, and at least one of the following conditions applies:

Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP (eg., combined oral contraceptive pill) from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit.

Non-reproductive potential defined as either:

• Pre-menopausal with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; or documented bilateral oophorectomy, or;

• Postmenopausal defined as 12 months of spontaneous amenorrhea and age appropriate (i.e., >50 years). In questionable cases, a blood sample with simultaneous follicle stimulating hormone >40 milli-International units/milliliters (mL) and estradiol <40 picograms/mL (<140 picomoles/L) is confirmatory, depending on local laboratory ranges. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment

• For the regular use of other medications (does not include protocol excluded medications), subjects must be on a stable dose for at least 4 weeks before screening

• Capable of giving signed informed consent; which includes compliance with the requirements and restrictions listed in the consent form and in this protocol

Exclusion Criteria:

• Type 1 diabetes mellitus

• Type 2 diabetes mellitus treated with more than one OAM or with chronic use of insulin within 3 months prior to screening

• Hemoglobin <11 grams (g)/dL (<110 g/L) for male subjects and <10 g/dL (<100 g/L) for female subjects at screening

• Fasting triglyceride level >500 mg/dL at screening

• Hemoglobinopathy that may affect proper interpretation of HbA1c

• History of cancer that has not been in full remission for at least 3 years before screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed).

• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

• History of acute or chronic pancreatitis.

• History or current severe lactose intolerance

• History of thyroid dysfunction or an abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at screening.

• Alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN).

• Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

• Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).

• Clinical diagnosis of gastroparesis.

• History of significant GI medical conditions such as chronic esophagitis, peptic ulcer diseases, celiac disease, inflammatory bowel disease, unexplained abdominal pain or irritable bowel syndrome and/or history of surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function (e.g., gastric bypass, gastric banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function).

• History of hypoglycemia unawareness (i.e., the absence of autonomic warning symptoms before the development of neuroglycopenic symptoms such as blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion).

• Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product or may influence data interpretation.

• Clinically significant cardiovascular and/or cerebrovascular disease at any time, such as prior myocardial infarction, unstable angina, stroke, transient ischemic attack or documented heart failure, before screening.

• Estimated glomerular filtration rate (eGFR) <=75 mL/min/1.73 m^2 (calculated using the MDRD formula) at screening.

• Lung diseases associated with pulmonary dysfunction (e.g. chronic obstructive pulmonary disease).

• A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied should be excluded unless the investigator (in consultation with the Medical Monitor, if necessary) decides and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or ability to interpret study results

• Unable to refrain from medications that might modify GMA or GI motility, such as prokinetics (e.g., erythromycin), anti-emetics (e.g., metoclopromide), narcotics (e.g., morphine), anticholinergics (e.g.,domperidone), anti-acids (e.g., proton pump inhibitors, H2 blockers) and laxatives, received within 7 days prior to screening or high likelihood of a requirement during the study.

• Use of oral or systemically injected glucocorticoids within the 3 months prior to randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 4months following randomization. However, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the Medical Monitor. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed

• Known allergy to albiglutide, exenatide or any product components (including yeast and human albumin), any other glucagon-like receptor 1 analogue, or other study treatment excipients OR other contraindications (per the principal investigator) for the use of potential study treatment.

• Intolerance or allergy to any component of GE test meal

• Received any glucagon-like peptide 1 receptor agonist at any time

• Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization.

• Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Louisville	Kentucky	United States	40213
2	GSK Investigational Site	Dallas	Texas	United States	75230

Sponsors and Collaborators

• GlaxoSmithKline
• Wake Forrest Baptist Health

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Jun 23, 2016
• Statistical Analysis Plan - Aug 17, 2017

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02793154
• Other Study ID Numbers: 204879
• First Posted: Jun 8, 2016
• Last Update Posted: Oct 30, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by GlaxoSmithKline: gastric emptying; albiglutide; GMA; exenatide; type 2 diabetes mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Exenatide; rGLP-1 protein

Study Results

Participant Flow

Recruitment Details	This study compared effects of repeated doses of albiglutide and exenatide in type 2 diabetes mellitus. This study was conducted in two parts; first cohort of participants (Par.) were planned to receive exenatide (Part A) and second cohort with albiglutide or exenatide (Part B). There were no pre-specified Primary or Secondary endpoints for Part A.
Pre-assignment Detail	This study was terminated during exploratory Part A due to the difficulty with enrollment and Part B was cancelled. Hence, Par. received only exenatide subcutaneous (SC) injection in Part A. The data was only collected in Part A and no Par. were enrolled in Part B. All the 4 enrolled Par. completed Part A and no Par. was withdrawn from study.

Arm/Group Title	Part A: Exenatide SC Injection	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Period Title: Part A (Single Group-up to 12 Days)
STARTED	4	0	0
COMPLETED	4	0	0
NOT COMPLETED	0	0	0
Period Title: Part A (Single Group-up to 12 Days)
STARTED	0	0	0
COMPLETED	0	0	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Part A: Exenatide SC Injection	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection	Total
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.	Total of all reporting groups
Overall Participants	4	0	0	4
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	56.8 (3.30)	56.8 (3.30)
Sex: Female, Male (Count of Participants)
Female	1 25%	1 Infinity
Male	3 75%	3 Infinity
Race/Ethnicity, Customized (Count of Participants)
African American/African Heritage	2 50%	2 Infinity
White-White/Causasian/European Heritage	2 50%	2 Infinity

Outcome Measures

1. Primary Outcome

Title	Part A: Distribution of Average Power by Frequency Region
Description	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.
Time Frame	Up to Day 4

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day 1; Pre-WL; Bradygastria	56.15
Par. 1; Day 1; Pre-WL; Normal	23.49
Par. 1; Day 1; Pre-WL; Tachygastria	17
Par. 1; Day 1; Pre-WL; Duodenal	3.35
Par. 1; Day 1; 10 minutes Post-WL; Bradygastria	93.97
Par. 1; Day 1; 10 minutes Post-WL; Normal	2.9
Par. 1; Day 1; 10 minutes Post-WL; Tachygastria	2.4
Par. 1; Day 1; 10 minutes Post-WL; Duodenal	0.73
Par. 1; Day 1; 20 minutes Post-WL; Bradygastria	57.13
Par. 1; Day 1; 20 minutes Post-WL; Normal	23.29
Par. 1; Day 1; 20 minutes Post-WL; Tachygastria	13.17
Par. 1; Day 1; 20 minutes Post-WL; Duodenal	6.41
Par. 1; Day 1; 30 minutes Post-WL; Bradygastria	43.44
Par. 1; Day 1; 30 minutes Post-WL; Normal	36.16
Par. 1; Day 1; 30 minutes Post-WL; Tachygastria	17.78
Par. 1; Day 1; 30 minutes Post-WL; Duodenal	2.62
Par. 1; Day 4; Pre-WL; Bradygastria	71.94
Par. 1; Day 4; Pre-WL; Normal	13
Par. 1; Day 4; Pre-WL; Tachygastria	9.51
Par. 1; Day 4; Pre-WL; Duodenal	5.55
Par. 1; Day 4; 10 minutes Post-WL; Bradygastria	43.99
Par. 1; Day 4; 10 minutes Post-WL; Normal	12.94
Par. 1; Day 4; 10 minutes Post-WL; Tachygastria	28.33
Par. 1; Day 4; 10 minutes Post-WL; Duodenal	14.74
Par. 1; Day 4; 20 minutes Post-WL; Bradygastria	73.87
Par. 1; Day 4; 20 minutes Post-WL; Normal	10.97
Par. 1; Day 4; 20 minutes Post-WL; Tachygastria	8.77
Par. 1; Day 4; 20 minutes Post-WL; Duodenal	6.39
Par. 1; Day 4; 30 minutes Post-WL; Bradygastria	48.87
Par. 1; Day 4; 30 minutes Post-WL; Normal	16.66
Par. 1; Day 4; 30 minutes Post-WL; Tachygastria	23.16
Par. 1; Day 4; 30 minutes Post-WL; Duodenal	11.31
Par. 2; Day 1; Pre-WL; Bradygastria	67.44
Par. 2; Day 1; Pre-WL; Normal	10.67
Par. 2; Day 1; Pre-WL; Tachygastria	17.2
Par. 2; Day 1; Pre-WL; Duodenal	4.68
Par. 2; Day 1; 10 minutes Post-WL; Bradygastria	94.05
Par. 2; Day 1; 10 minutes Post-WL; Normal	2.46
Par. 2; Day 1; 10 minutes Post-WL; Tachygastria	2.83
Par. 2; Day 1; 10 minutes Post-WL; Duodenal	0.67
Par. 2; Day 1; 20 minutes Post-WL; Bradygastria	85.64
Par. 2; Day 1; 20 minutes Post-WL; Normal	11.72
Par. 2; Day 1; 20 minutes Post-WL; Tachygastria	2.43
Par. 2; Day 1; 20 minutes Post-WL; Duodenal	0.22
Par. 2; Day 1; 30 minutes Post-WL; Bradygastria	77.34
Par. 2; Day 1; 30 minutes Post-WL; Normal	15.57
Par. 2; Day 1; 30 minutes Post-WL; Tachygastria	6.23
Par. 2; Day 1; 30 minutes Post-WL; Duodenal	0.86
Par. 2; Day 4; Pre-WL; Bradygastria	43.32
Par. 2; Day 4; Pre-WL; Normal	23.82
Par. 2; Day 4; Pre-WL; Tachygastria	18.71
Par. 2; Day 4; Pre-WL; Duodenal	14.14
Par. 2; Day 4; 10 minutes Post-WL; Bradygastria	84.23
Par. 2; Day 4; 10 minutes Post-WL; Normal	7.93
Par. 2; Day 4; 10 minutes Post-WL; Tachygastria	6.81
Par. 2; Day 4; 10 minutes Post-WL; Duodenal	1.02
Par. 2; Day 4; 20 minutes Post-WL; Bradygastria	66.32
Par. 2; Day 4; 20 minutes Post-WL; Normal	19.43
Par. 2; Day 4; 20 minutes Post-WL; Tachygastria	11.7
Par. 2; Day 4; 20 minutes Post-WL; Duodenal	2.55
Par. 2; Day 4; 30 minutes Post-WL; Bradygastria	73.05
Par. 2; Day 4; 30 minutes Post-WL; Normal	19.64
Par. 2; Day 4; 30 minutes Post-WL; Tachygastria	6.47
Par. 2; Day 4; 30 minutes Post-WL; Duodenal	0.84
Par. 3; Day 1; Pre-WL; Bradygastria	59.66
Par. 3; Day 1; Pre-WL; Normal	9.05
Par. 3; Day 1; Pre-WL; Tachygastria	22.39
Par. 3; Day 1; Pre-WL; Duodenal	8.91
Par. 3; Day 1; 10 minutes Post-WL; Bradygastria	32.73
Par. 3; Day 1; 10 minutes Post-WL; Normal	11.03
Par. 3; Day 1; 10 minutes Post-WL; Tachygastria	48.77
Par. 3; Day 1; 10 minutes Post-WL; Duodenal	7.47
Par. 3; Day 1; 20 minutes Post-WL; Bradygastria	29.94
Par. 3; Day 1; 20 minutes Post-WL; Normal	22.84
Par. 3; Day 1; 20 minutes Post-WL; Tachygastria	39.72
Par. 3; Day 1; 20 minutes Post-WL; Duodenal	7.5
Par. 3; Day 1; 30 minutes Post-WL; Bradygastria	16.32
Par. 3; Day 1; 30 minutes Post-WL; Normal	22.48
Par. 3; Day 1; 30 minutes Post-WL; Tachygastria	54.77
Par. 3; Day 1; 30 minutes Post-WL; Duodenal	6.43
Par. 3; Day 4; Pre-WL; Bradygastria	52.85
Par. 3; Day 4; Pre-WL; Normal	16.64
Par. 3; Day 4; Pre-WL; Tachygastria	13.21
Par. 3; Day 4; Pre-WL; Duodenal	17.29
Par. 3; Day 4; 10 minutes Post-WL; Bradygastria	64.27
Par. 3; Day 4; 10 minutes Post-WL; Normal	10.37
Par. 3; Day 4; 10 minutes Post-WL; Tachygastria	13.26
Par. 3; Day 4; 10 minutes Post-WL; Duodenal	12.1
Par. 3; Day 4; 20 minutes Post-WL; Bradygastria	71.66
Par. 3; Day 4; 20 minutes Post-WL; Normal	11.11
Par. 3; Day 4; 20 minutes Post-WL; Tachygastria	9.52
Par. 3; Day 4; 20 minutes Post-WL; Duodenal	7.72
Par. 3; Day 4; 30 minutes Post-WL; Bradygastria	53.97
Par. 3; Day 4; 30 minutes Post-WL; Normal	8.61
Par. 3; Day 4; 30 minutes Post-WL; Tachygastria	16.12
Par. 3; Day 4; 30 minutes Post-WL; Duodenal	21.3
Par. 4; Day 1; Pre-WL; Bradygastria	82.47
Par. 4; Day 1; Pre-WL; Normal	6.66
Par. 4; Day 1; Pre-WL; Tachygastria	7.86
Par. 4; Day 1; Pre-WL; Duodenal	3.01
Par. 4; Day 1; 10 minutes Post-WL; Bradygastria	81.89
Par. 4; Day 1; 10 minutes Post-WL; Normal	5.6
Par. 4; Day 1; 10 minutes Post-WL; Tachygastria	11.63
Par. 4; Day 1; 10 minutes Post-WL; Duodenal	0.88
Par. 4; Day 1; 20 minutes Post-WL; Bradygastria	62.96
Par. 4; Day 1; 20 minutes Post-WL; Normal	12.84
Par. 4; Day 1; 20 minutes Post-WL; Tachygastria	17.04
Par. 4; Day 1; 20 minutes Post-WL; Duodenal	7.17
Par. 4; Day 1; 30 minutes Post-WL; Bradygastria	73.64
Par. 4; Day 1; 30 minutes Post-WL; Normal	12.7
Par. 4; Day 1; 30 minutes Post-WL; Tachygastria	11.1
Par. 4; Day 1; 30 minutes Post-WL; Duodenal	2.56
Par. 4; Day 4; Pre-WL; Bradygastria	54.98
Par. 4; Day 4; Pre-WL; Normal	17.6
Par. 4; Day 4; Pre-WL; Tachygastria	22.97
Par. 4; Day 4; Pre-WL; Duodenal	4.45
Par. 4; Day 4; 10 minutes Post-WL; Bradygastria	83.7
Par. 4; Day 4; 10 minutes Post-WL; Normal	4.2
Par. 4; Day 4; 10 minutes Post-WL; Tachygastria	10.69
Par. 4; Day 4; 10 minutes Post-WL; Duodenal	1.4
Par. 4; Day 4; 20 minutes Post-WL; Bradygastria	82.96
Par. 4; Day 4; 20 minutes Post-WL; Normal	5.92
Par. 4; Day 4; 20 minutes Post-WL; Tachygastria	10.1
Par. 4; Day 4; 20 minutes Post-WL; Duodenal	1.02
Par. 4; Day 4; 30 minutes Post-WL; Bradygastria	39.01
Par. 4; Day 4; 30 minutes Post-WL; Normal	42.61
Par. 4; Day 4; 30 minutes Post-WL; Tachygastria	16.77
Par. 4; Day 4; 30 minutes Post-WL; Duodenal	1.62

2. Primary Outcome

Title	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Description	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.
Time Frame	Up to Day 4

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day 1; 10 minutes Post-WL; Bradygastria	0
Par. 1; Day 1; 10 minutes Post-WL; Normal	0
Par. 1; Day 1; 10 minutes Post-WL; Tachygastria	0
Par. 1; Day 1; 10 minutes Post-WL; Duodenal	0
Par. 1; Day 1; 20 minutes Post-WL; Bradygastria	0
Par. 1; Day 1; 20 minutes Post-WL; Normal	0
Par. 1; Day 1; 20 minutes Post-WL; Tachygastria	0
Par. 1; Day 1; 20 minutes Post-WL; Duodenal	0
Par. 1; Day 1; 30 minutes Post-WL; Bradygastria	0
Par. 1; Day 1; 30 minutes Post-WL; Normal	0
Par. 1; Day 1; 30 minutes Post-WL; Tachygastria	0
Par. 1; Day 1; 30 minutes Post-WL; Duodenal	0
Par. 1; Day 4; 10 minutes Post-WL; Bradygastria	0
Par. 1; Day 4; 10 minutes Post-WL; Normal	0
Par. 1; Day 4; 10 minutes Post-WL; Tachygastria	0
Par. 1; Day 4; 10 minutes Post-WL; Duodenal	0
Par. 1; Day 4; 20 minutes Post-WL; Bradygastria	0
Par. 1; Day 4; 20 minutes Post-WL; Normal	0
Par. 1; Day 4; 20 minutes Post-WL; Tachygastria	0
Par. 1; Day 4; 20 minutes Post-WL; Duodenal	0
Par. 1; Day 4; 30 minutes Post-WL; Bradygastria	0
Par. 1; Day 4; 30 minutes Post-WL; Normal	0
Par. 1; Day 4; 30 minutes Post-WL; Tachygastria	0
Par. 1; Day 4; 30 minutes Post-WL; Duodenal	0
Par. 2; Day 1; 10 minutes Post-WL; Bradygastria	0.01
Par. 2; Day 1; 10 minutes Post-WL; Normal	0
Par. 2; Day 1; 10 minutes Post-WL; Tachygastria	0
Par. 2; Day 1; 10 minutes Post-WL; Duodenal	0
Par. 2; Day 1; 20 minutes Post-WL; Bradygastria	0.04
Par. 2; Day 1; 20 minutes Post-WL; Normal	0.04
Par. 2; Day 1; 20 minutes Post-WL; Tachygastria	0
Par. 2; Day 1; 20 minutes Post-WL; Duodenal	0
Par. 2; Day 1; 30 minutes Post-WL; Bradygastria	0.01
Par. 2; Day 1; 30 minutes Post-WL; Normal	0.02
Par. 2; Day 1; 30 minutes Post-WL; Tachygastria	0
Par. 2; Day 1; 30 minutes Post-WL; Duodenal	0
Par. 2; Day 4; 10 minutes Post-WL; Bradygastria	0.03
Par. 2; Day 4; 10 minutes Post-WL; Normal	0
Par. 2; Day 4; 10 minutes Post-WL; Tachygastria	0
Par. 2; Day 4; 10 minutes Post-WL; Duodenal	0
Par. 2; Day 4; 20 minutes Post-WL; Bradygastria	0.03
Par. 2; Day 4; 20 minutes Post-WL; Normal	0.02
Par. 2; Day 4; 20 minutes Post-WL; Tachygastria	0.01
Par. 2; Day 4; 20 minutes Post-WL; Duodenal	0
Par. 2; Day 4; 30 minutes Post-WL; Bradygastria	0.22
Par. 2; Day 4; 30 minutes Post-WL; Normal	0.11
Par. 2; Day 4; 30 minutes Post-WL; Tachygastria	0.05
Par. 2; Day 4; 30 minutes Post-WL; Duodenal	0.01
Par. 3; Day 1; 10 minutes Post-WL; Bradygastria	0.13
Par. 3; Day 1; 10 minutes Post-WL; Normal	0.29
Par. 3; Day 1; 10 minutes Post-WL; Tachygastria	0.52
Par. 3; Day 1; 10 minutes Post-WL; Duodenal	0.2
Par. 3; Day 1; 20 minutes Post-WL; Bradygastria	0.2
Par. 3; Day 1; 20 minutes Post-WL; Normal	0.99
Par. 3; Day 1; 20 minutes Post-WL; Tachygastria	0.7
Par. 3; Day 1; 20 minutes Post-WL; Duodenal	0.33
Par. 3; Day 1; 30 minutes Post-WL; Bradygastria	0.15
Par. 3; Day 1; 30 minutes Post-WL; Normal	1.38
Par. 3; Day 1; 30 minutes Post-WL; Tachygastria	1.36
Par. 3; Day 1; 30 minutes Post-WL; Duodenal	0.4
Par. 3; Day 4; 10 minutes Post-WL; Bradygastria	0.16
Par. 3; Day 4; 10 minutes Post-WL; Normal	0.08
Par. 3; Day 4; 10 minutes Post-WL; Tachygastria	0.13
Par. 3; Day 4; 10 minutes Post-WL; Duodenal	0.09
Par. 3; Day 4; 20 minutes Post-WL; Bradygastria	0.2
Par. 3; Day 4; 20 minutes Post-WL; Normal	0.1
Par. 3; Day 4; 20 minutes Post-WL; Tachygastria	0.11
Par. 3; Day 4; 20 minutes Post-WL; Duodenal	0.07
Par. 3; Day 4; 30 minutes Post-WL; Bradygastria	0.16
Par. 3; Day 4; 30 minutes Post-WL; Normal	0.08
Par. 3; Day 4; 30 minutes Post-WL; Tachygastria	0.19
Par. 3; Day 4; 30 minutes Post-WL; Duodenal	0.19
Par. 4; Day 1; 10 minutes Post-WL; Bradygastria	2.6
Par. 4; Day 1; 10 minutes Post-WL; Normal	2.21
Par. 4; Day 1; 10 minutes Post-WL; Tachygastria	3.88
Par. 4; Day 1; 10 minutes Post-WL; Duodenal	0.76
Par. 4; Day 1; 20 minutes Post-WL; Bradygastria	0.89
Par. 4; Day 1; 20 minutes Post-WL; Normal	2.24
Par. 4; Day 1; 20 minutes Post-WL; Tachygastria	2.52
Par. 4; Day 1; 20 minutes Post-WL; Duodenal	2.76
Par. 4; Day 1; 30 minutes Post-WL; Bradygastria	1.54
Par. 4; Day 1; 30 minutes Post-WL; Normal	3.29
Par. 4; Day 1; 30 minutes Post-WL; Tachygastria	2.44
Par. 4; Day 1; 30 minutes Post-WL; Duodenal	1.47
Par. 4; Day 4; 10 minutes Post-WL; Bradygastria	4.7
Par. 4; Day 4; 10 minutes Post-WL; Normal	0.74
Par. 4; Day 4; 10 minutes Post-WL; Tachygastria	1.44
Par. 4; Day 4; 10 minutes Post-WL; Duodenal	0.97
Par. 4; Day 4; 20 minutes Post-WL; Bradygastria	10.24
Par. 4; Day 4; 20 minutes Post-WL; Normal	2.28
Par. 4; Day 4; 20 minutes Post-WL; Tachygastria	2.98
Par. 4; Day 4; 20 minutes Post-WL; Duodenal	1.55
Par. 4; Day 4; 30 minutes Post-WL; Bradygastria	3.4
Par. 4; Day 4; 30 minutes Post-WL; Normal	11.6
Par. 4; Day 4; 30 minutes Post-WL; Tachygastria	3.5
Par. 4; Day 4; 30 minutes Post-WL; Duodenal	1.74

3. Primary Outcome

Title	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Description	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.
Time Frame	Up to Day 4

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day 1; Pre-WL; Bradygastria	80
Par. 1; Day 1; Pre-WL; Normal	20
Par. 1; Day 1; Pre-WL; Tachygastria	0
Par. 1; Day 1; Pre-WL; Duodenal	0
Par. 1; Day 1; 10 minutes Post-WL; Bradygastria	100
Par. 1; Day 1; 10 minutes Post-WL; Normal	0
Par. 1; Day 1; 10 minutes Post-WL; Tachygastria	0
Par. 1; Day 1; 10 minutes Post-WL; Duodenal	0
Par. 1; Day 1; 20 minutes Post-WL; Bradygastria	100
Par. 1; Day 1; 20 minutes Post-WL; Normal	0
Par. 1; Day 1; 20 minutes Post-WL; Tachygastria	0
Par. 1; Day 1; 20 minutes Post-WL; Duodenal	0
Par. 1; Day 1; 30 minutes Post-WL; Bradygastria	50
Par. 1; Day 1; 30 minutes Post-WL; Normal	50
Par. 1; Day 1; 30 minutes Post-WL; Tachygastria	0
Par. 1; Day 1; 30 minutes Post-WL; Duodenal	0
Par. 1; Day 4; Pre-WL; Bradygastria	100
Par. 1; Day 4; Pre-WL; Normal	0
Par. 1; Day 4; Pre-WL; Tachygastria	0
Par. 1; Day 4; Pre-WL; Duodenal	0
Par. 1; Day 4; 10 minutes Post-WL; Bradygastria	100
Par. 1; Day 4; 10 minutes Post-WL; Normal	0
Par. 1; Day 4; 10 minutes Post-WL; Tachygastria	0
Par. 1; Day 4; 10 minutes Post-WL; Duodenal	0
Par. 1; Day 4; 20 minutes Post-WL; Bradygastria	100
Par. 1; Day 4; 20 minutes Post-WL; Normal	0
Par. 1; Day 4; 20 minutes Post-WL; Tachygastria	0
Par. 1; Day 4; 20 minutes Post-WL; Duodenal	0
Par. 1; Day 4; 30 minutes Post-WL; Bradygastria	50
Par. 1; Day 4; 30 minutes Post-WL; Normal	50
Par. 1; Day 4; 30 minutes Post-WL; Tachygastria	0
Par. 1; Day 4; 30 minutes Post-WL; Duodenal	0
Par. 2; Day 1; Pre-WL; Bradygastria	100
Par. 2; Day 1; Pre-WL; Normal	0
Par. 2; Day 1; Pre-WL; Tachygastria	0
Par. 2; Day 1; Pre-WL; Duodenal	0
Par. 2; Day 1; 10 minutes Post-WL; Bradygastria	100
Par. 2; Day 1; 10 minutes Post-WL; Normal	0
Par. 2; Day 1; 10 minutes Post-WL; Tachygastria	0
Par. 2; Day 1; 10 minutes Post-WL; Duodenal	0
Par. 2; Day 1; 20 minutes Post-WL; Bradygastria	100
Par. 2; Day 1; 20 minutes Post-WL; Normal	0
Par. 2; Day 1; 20 minutes Post-WL; Tachygastria	0
Par. 2; Day 1; 20 minutes Post-WL; Duodenal	0
Par. 2; Day 1; 30 minutes Post-WL; Bradygastria	100
Par. 2; Day 1; 30 minutes Post-WL; Normal	0
Par. 2; Day 1; 30 minutes Post-WL; Tachygastria	0
Par. 2; Day 1; 30 minutes Post-WL; Duodenal	0
Par. 2; Day 4; Pre-WL; Bradygastria	100
Par. 2; Day 4; Pre-WL; Normal	0
Par. 2; Day 4; Pre-WL; Tachygastria	0
Par. 2; Day 4; Pre-WL; Duodenal	0
Par. 2; Day 4; 10 minutes Post-WL; Bradygastria	100
Par. 2; Day 4; 10 minutes Post-WL; Normal	0
Par. 2; Day 4; 10 minutes Post-WL; Tachygastria	0
Par. 2; Day 4; 10 minutes Post-WL; Duodenal	0
Par. 2; Day 4; 20 minutes Post-WL; Bradygastria	100
Par. 2; Day 4; 20 minutes Post-WL; Normal	0
Par. 2; Day 4; 20 minutes Post-WL; Tachygastria	0
Par. 2; Day 4; 20 minutes Post-WL; Duodenal	0
Par. 2; Day 4; 30 minutes Post-WL; Bradygastria	50
Par. 2; Day 4; 30 minutes Post-WL; Normal	50
Par. 2; Day 4; 30 minutes Post-WL; Tachygastria	0
Par. 2; Day 4; 30 minutes Post-WL; Duodenal	0
Par. 3; Day 1; Pre-WL; Bradygastria	100
Par. 3; Day 1; Pre-WL; Normal	0
Par. 3; Day 1; Pre-WL; Tachygastria	0
Par. 3; Day 1; Pre-WL; Duodenal	0
Par. 3; Day 1; 10 minutes Post-WL; Bradygastria	100
Par. 3; Day 1; 10 minutes Post-WL; Normal	0
Par. 3; Day 1; 10 minutes Post-WL; Tachygastria	0
Par. 3; Day 1; 10 minutes Post-WL; Duodenal	0
Par. 3; Day 1; 20 minutes Post-WL; Bradygastria	0
Par. 3; Day 1; 20 minutes Post-WL; Normal	100
Par. 3; Day 1; 20 minutes Post-WL; Tachygastria	0
Par. 3; Day 1; 20 minutes Post-WL; Duodenal	0
Par. 3; Day 1; 30 minutes Post-WL; Bradygastria	0
Par. 3; Day 1; 30 minutes Post-WL; Normal	50
Par. 3; Day 1; 30 minutes Post-WL; Tachygastria	50
Par. 3; Day 1; 30 minutes Post-WL; Duodenal	0
Par. 3; Day 4; Pre-WL; Bradygastria	100
Par. 3; Day 4; Pre-WL; Normal	0
Par. 3; Day 4; Pre-WL; Tachygastria	0
Par. 3; Day 4; Pre-WL; Duodenal	0
Par. 3; Day 4; 10 minutes Post-WL; Bradygastria	100
Par. 3; Day 4; 10 minutes Post-WL; Normal	0
Par. 3; Day 4; 10 minutes Post-WL; Tachygastria	0
Par. 3; Day 4; 10 minutes Post-WL; Duodenal	0
Par. 3; Day 4; 20 minutes Post-WL; Bradygastria	100
Par. 3; Day 4; 20 minutes Post-WL; Normal	0
Par. 3; Day 4; 20 minutes Post-WL; Tachygastria	0
Par. 3; Day 4; 20 minutes Post-WL; Duodenal	0
Par. 3; Day 4; 30 minutes Post-WL; Bradygastria	100
Par. 3; Day 4; 30 minutes Post-WL; Normal	0
Par. 3; Day 4; 30 minutes Post-WL; Tachygastria	0
Par. 3; Day 4; 30 minutes Post-WL; Duodenal	0
Par. 4; Day 1; Pre-WL; Bradygastria	100
Par. 4; Day 1; Pre-WL; Normal	0
Par. 4; Day 1; Pre-WL; Tachygastria	0
Par. 4; Day 1; Pre-WL; Duodenal	0
Par. 4; Day 1; 10 minutes Post-WL; Bradygastria	100
Par. 4; Day 1; 10 minutes Post-WL; Normal	0
Par. 4; Day 1; 10 minutes Post-WL; Tachygastria	0
Par. 4; Day 1; 10 minutes Post-WL; Duodenal	0
Par. 4; Day 1; 20 minutes Post-WL; Bradygastria	100
Par. 4; Day 1; 20 minutes Post-WL; Normal	0
Par. 4; Day 1; 20 minutes Post-WL; Tachygastria	0
Par. 4; Day 1; 20 minutes Post-WL; Duodenal	0
Par. 4; Day 1; 30 minutes Post-WL; Bradygastria	100
Par. 4; Day 1; 30 minutes Post-WL; Normal	0
Par. 4; Day 1; 30 minutes Post-WL; Tachygastria	0
Par. 4; Day 1; 30 minutes Post-WL; Duodenal	0
Par. 4; Day 4; Pre-WL; Bradygastria	100
Par. 4; Day 4; Pre-WL; Normal	0
Par. 4; Day 4; Pre-WL; Tachygastria	0
Par. 4; Day 4; Pre-WL; Duodenal	0
Par. 4; Day 4; 10 minutes Post-WL; Bradygastria	100
Par. 4; Day 4; 10 minutes Post-WL; Normal	0
Par. 4; Day 4; 10 minutes Post-WL; Tachygastria	0
Par. 4; Day 4; 10 minutes Post-WL; Duodenal	0
Par. 4; Day 4; 20 minutes Post-WL; Bradygastria	100
Par. 4; Day 4; 20 minutes Post-WL; Normal	0
Par. 4; Day 4; 20 minutes Post-WL; Tachygastria	0
Par. 4; Day 4; 20 minutes Post-WL; Duodenal	0
Par. 4; Day 4; 30 minutes Post-WL; Bradygastria	0
Par. 4; Day 4; 30 minutes Post-WL; Normal	80
Par. 4; Day 4; 30 minutes Post-WL; Tachygastria	20
Par. 4; Day 4; 30 minutes Post-WL; Duodenal	0

4. Primary Outcome

Title	Part A: Number of Par. With Shifts in Gastric Rhythm Status
Description	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.
Time Frame	Up to 12 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	0

5. Primary Outcome

Title	Part A: Number Par. by Gastric Rhythm Status
Description	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.
Time Frame	Up to 12 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	0

6. Primary Outcome

Title	Part A: Average Dominant Frequency
Description	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.
Time Frame	Up to Day 4

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day 1; Pre-WL; Bradygastria	1.5
Par. 1; Day 1; 10 minutes Post-WL; Bradygastria	0.75
Par. 1; Day 1; 20 minutes Post-WL; Bradygastria	1.25
Par. 1; Day 1; 30 minutes Post-WL; Bradygastria	2.19
Par. 1; Day 4; Pre-WL; Bradygastria	1.05
Par. 1; Day 4; 10 minutes Post-WL; Bradygastria	0.96
Par. 1; Day 4; 20 minutes Post-WL; Bradygastria	1.25
Par. 1; Day 4; 30 minutes Post-WL; Bradygastria	2.38
Par. 2; Day 1; Pre-WL; Bradygastria	1
Par. 2; Day 1; 10 minutes Post-WL; Bradygastria	1
Par. 2; Day 1; 20 minutes Post-WL; Bradygastria	1.5
Par. 2; Day 1; 30 minutes Post-WL; Bradygastria	1.75
Par. 2; Day 4; Pre-WL; Bradygastria	0.75
Par. 2; Day 4; 10 minutes Post-WL; Bradygastria	1.38
Par. 2; Day 4; 20 minutes Post-WL; Bradygastria	1
Par. 2; Day 4; 30 minutes Post-WL; Bradygastria	2.42
Par. 3; Day 1; Pre-WL; Bradygastria	0.96
Par. 3; Day 1; 10 minutes Post-WL; Bradygastria	1.83
Par. 3; Day 1; 20 minutes Post-WL; Normal	3
Par. 3; Day 1; 30 minutes Post-WL; Tachygastria	4.13
Par. 3; Day 4; Pre-WL; Bradygastria	1.2
Par. 3; Day 4; 10 minutes Post-WL; Bradygastria	1.5
Par. 3; Day 4; 20 minutes Post-WL; Bradygastria	0.94
Par. 3; Day 4; 30 minutes Post-WL; Bradygastria	1.5
Par. 4; Day 1; Pre-WL; Bradygastria	0.86
Par. 4; Day 1; 10 minutes Post-WL; Bradygastria	1.88
Par. 4; Day 1; 20 minutes Post-WL; Bradygastria	1.7
Par. 4; Day 1; 30 minutes Post-WL; Bradygastria	1.19
Par. 4; Day 4; Pre-WL; Bradygastria	1.2
Par. 4; Day 4; 10 minutes Post-WL; Bradygastria	0.94
Par. 4; Day 4; 20 minutes Post-WL; Bradygastria	1.29
Par. 4; Day 4; 30 minutes Post-WL; Normal	2.9

7. Primary Outcome

Title	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Description	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.
Time Frame	Day 4

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day 4; Pre-WL	4
Par. 1; Day 4; 10 minutes Post-WL	2
Par. 1; Day 4; 20 minutes Post-WL	4
Par. 1; Day 4; 30 minutes Post-WL	3
Par. 2; Day 4; Pre-WL	3
Par. 2; Day 4; 10 minutes Post-WL	4
Par. 2; Day 4; 20 minutes Post-WL	4
Par. 2; Day 4; 30 minutes Post-WL	24
Par. 3; Day 4; Pre-WL	1
Par. 3; Day 4; 10 minutes Post-WL	0
Par. 3; Day 4; 20 minutes Post-WL	0
Par. 3; Day 4; 30 minutes Post-WL	0
Par. 4; Day 4; Pre-WL	4
Par. 4; Day 4; 10 minutes Post-WL	5
Par. 4; Day 4; 20 minutes Post-WL	3
Par. 4; Day 4; 30 minutes Post-WL	4

8. Primary Outcome

Title	Part A: Time to Half-gastric Emptying
Description	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.
Time Frame	Up to Day 5

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day -1	87.2
Par. 1; Day 5	226.5
Par. 2; Day -1	73.0
Par. 2; Day 5	75.5
Par. 3; Day -1	57.6
Par. 3; Day 5	174.0
Par. 4; Day -1	52.9
Par. 4; Day 5	103.8

9. Primary Outcome

Title	Part A: Rate of [13]C Dose Excreted in Breath
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day 5; Pre-Meal	0
Par. 1; Day 5; 45 Minutes Post-Meal	1.8
Par. 1; Day 5; 90 Minutes Post-Meal	3.3
Par. 1; Day 5; 120 Minutes Post-Meal	3.1
Par. 1; Day 5; 150 Minutes Post-Meal	3.3
Par. 1; Day 5; 180 Minutes Post-Meal	7.4
Par. 1; Day 5; 240 Minutes Post-Meal	21.1
Par. 2; Day 5; Pre-Meal	0
Par. 2; Day 5; 45 Minutes Post-Meal	22.2
Par. 2; Day 5; 90 Minutes Post-Meal	42.5
Par. 2; Day 5; 120 Minutes Post-Meal	66.5
Par. 2; Day 5; 150 Minutes Post-Meal	82.3
Par. 2; Day 5; 180 Minutes Post-Meal	84.7
Par. 2; Day 5; 240 Minutes Post-Meal	75.8
Par. 3; Day 5; Pre-Meal	0
Par. 3; Day 5; 45 Minutes Post-Meal	1
Par. 3; Day 5; 90 Minutes Post-Meal	2.3
Par. 3; Day 5; 120 Minutes Post-Meal	6.5
Par. 3; Day 5; 150 Minutes Post-Meal	16.4
Par. 3; Day 5; 180 Minutes Post-Meal	28.2
Par. 3; Day 5; 240 Minutes Post-Meal	56.3
Par. 4; Day 5; Pre-Meal	0
Par. 4; Day 5; 45 Minutes Post-Meal	11.3
Par. 4; Day 5; 90 Minutes Post-Meal	27.8
Par. 4; Day 5; 120 Minutes Post-Meal	39.6
Par. 4; Day 5; 150 Minutes Post-Meal	51.1
Par. 4; Day 5; 180 Minutes Post-Meal	59.8
Par. 4; Day 5; 240 Minutes Post-Meal	61.6

10. Primary Outcome

Title	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Description	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.
Time Frame	Up to Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day-1; Epi of vomiting	0
Par. 1; Day 1; Epi of vomiting	0
Par. 1; Day 4; Epi of vomiting	0
Par. 1; Day 5; Epi of vomiting	0
Par. 1; Day -1; Epi of retching	0
Par. 1; Day 1; Epi of retching	0
Par. 1; Day 4; Epi of retching	0
Par. 1; Day 5; Epi of retching	0
Par 1; Day -1; Nausea	0
Par 1; Day 1; Nausea	0
Par 1; Day 4; Nausea	2
Par 1; Day 5; Nausea	1
Par 1; Day -1; Excessively full after meals	2
Par 1; Day 1; Excessively full after meals	2
Par 1; Day 4; Excessively full after meals	5
Par 1; Day 5; Excessively full after meals	2
Par 1; Day -1; Bloating	0
Par 1; Day 1; Bloating	0
Par 1; Day 4; Bloating	0
Par 1; Day 5; Bloating	5
Par 1; Day -1; Unable to finish normal-sized meal	2
Par 1; Day 1; Unable to finish normal-sized meal	2
Par 1; Day 4; Unable to finish normal-sized meal	5
Par 1; Day 5; Unable to finish normal-sized meal	2
Par 1; Day -1; Retching	0
Par 1; Day 1; Retching	0
Par 1; Day 4; Retching	2
Par 1; Day 5; Retching	1
Par 1; Day -1; Vomiting	0
Par 1; Day 1; Vomiting	0
Par 1; Day 4; Vomiting	0
Par 1; Day 5; Vomiting	0
Par 1; Day -1; Stomach or belly visibly larger	0
Par 1; Day 1; Stomach or belly visibly larger	0
Par 1; Day 4; Stomach or belly visibly larger	0
Par 1; Day 5; Stomach or belly visibly larger	0
Par 1; Day -1; Stomach fullness	2
Par 1; Day 1; Stomach fullness	2
Par 1; Day 4; Stomach fullness	5
Par 1; Day 5; Stomach fullness	5
Par 1; Day -1; Loss of appetite	2
Par 1; Day 1; Loss of appetite	2
Par 1; Day 4; Loss of appetite	0
Par 1; Day 5; Loss of appetite	2
Par 1; Day -1; Upper abdominal pain	0
Par 1; Day 1; Upper abdominal pain	0
Par 1; Day 4; Upper abdominal pain	0
Par 1; Day 5; Upper abdominal pain	3
Par 1; Day -1; Upper abdominal discomfort	0
Par 1; Day 1; Upper abdominal discomfort	0
Par 1; Day 4; Upper abdominal discomfort	0
Par 1; Day 5; Upper abdominal discomfort	3
Par 1; Day -1; Overall severity of gastroparesis	0
Par 1; Day 1; Overall severity of gastroparesis	0
Par 1; Day 4; Overall severity of gastroparesis	0
Par 1; Day 5; Overall severity of gastroparesis	4
Par. 2; Day -1; Epi of vomiting	0
Par. 2; Day 1; Epi of vomiting	0
Par. 2; Day 4; Epi of vomiting	0
Par. 2; Day 5; Epi of vomiting	0
Par. 2; Day -1; Epi of retching	0
Par. 2; Day 1; Epi of retching	0
Par. 2; Day 4; Epi of retching	0
Par. 2; Day 5; Epi of retching	0
Par. 2; Day -1; Nausea	0
Par. 2 Day 1; Nausea	0
Par. 2; Day 4; Nausea	0
Par. 2; Day 5; Nausea	0
Par. 2; Day -1; Excessively full after meals	0
Par. 2; Day 1; Excessively full after meals	0
Par. 2; Day 4; Excessively full after meals	0
Par. 2; Day 5; Excessively full after meals	0
Par. 2; Day -1; Bloating	0
Par. 2; Day 1; Bloating	0
Par. 2; Day 4; Bloating	0
Par. 2; Day 5; Bloating	0
Par. 2; Day -1; Unable to finish normal-sized meal	0
Par. 2; Day 1; Unable to finish normal-sized meal	0
Par. 2; Day 4; Unable to finish normal-sized meal	0
Par. 2; Day 5; Unable to finish normal-sized meal	0
Par. 2; Day -1; Retching	0
Par. 2; Day 1; Retching	0
Par. 2; Day 4; Retching	0
Par. 2; Day 5; Retching	0
Par. 2; Day -1; Vomiting	0
Par. 2; Day 1; Vomiting	0
Par. 2; Day 4; Vomiting	0
Par. 2; Day 5; Vomiting	0
Par. 2; Day -1; Stomach or belly visibly larger	0
Par. 2; Day 1; Stomach or belly visibly larger	0
Par. 2; Day 4; Stomach or belly visibly larger	0
Par. 2; Day 5; Stomach or belly visibly larger	0
Par. 2; Day -1; Stomach fullness	0
Par. 2; Day 1; Stomach fullness	0
Par. 2; Day 4; Stomach fullness	1
Par. 2; Day 5; Stomach fullness	0
Par. 2; Day -1; Loss of appetite	0
Par. 2; Day 1; Loss of appetite	0
Par. 2; Day 4; Loss of appetite	0
Par. 2; Day 5; Loss of appetite	0
Par. 2; Day -1; Upper abdominal pain	0
Par. 2; Day 1; Upper abdominal pain	0
Par. 2; Day 4; Upper abdominal pain	0
Par. 2; Day 5; Upper abdominal pain	0
Par. 2; Day -1; Upper abdominal discomfort	0
Par. 2; Day 1; Upper abdominal discomfort	0
Par. 2; Day 4; Upper abdominal discomfort	0
Par. 2; Day 5; Upper abdominal discomfort	0
Par. 2; Day -1; Overall severity of gastroparesis	0
Par. 2; Day 1; Overall severity of gastroparesis	0
Par. 2; Day 4; Overall severity of gastroparesis	0
Par. 2; Day 5; Overall severity of gastroparesis	0
Par. 3; Day -1; Epi of vomiting	0
Par. 3; Day 1; Epi of vomiting	0
Par. 3; Day 4; Epi of vomiting	0
Par. 3; Day 5; Epi of vomiting	0
Par. 3; Day -1; Epi of retching	0
Par. 3; Day 1; Epi of retching	0
Par. 3; Day 4; Epi of retching	0
Par. 3; Day 5; Epi of retching	0
Par. 3; Day -1; Nausea	0
Par. 3; Day 1; Nausea	0
Par. 3; Day 4; Nausea	0
Par. 3; Day 5; Nausea	0
Par. 3; Day -1; Excessively full after meals	0
Par. 3; Day 1; Excessively full after meals	0
Par. 3; Day 4; Excessively full after meals	0
Par. 3; Day 5; Excessively full after meals	0
Par. 3; Day -1; Bloating	0
Par. 3; Day 1; Bloating	0
Par. 3; Day 4; Bloating	0
Par. 3; Day 5; Bloating	0
Par. 3; Day -1; Unable to finish normal-sized meal	0
Par. 3; Day 1; Unable to finish normal-sized meal	0
Par. 3; Day 4; Unable to finish normal-sized meal	0
Par. 3; Day 5; Unable to finish normal-sized meal	0
Par. 3; Day -1; Retching	0
Par. 3; Day 1; Retching	0
Par. 3; Day 4; Retching	0
Par. 3; Day 5; Retching	0
Par. 3; Day -1; Vomiting	0
Par. 3; Day 1; Vomiting	0
Par. 3; Day 4; Vomiting	0
Par. 3; Day 5; Vomiting	0
Par. 3; Day -1; Stomach or belly visibly larger	0
Par. 3; Day 1; Stomach or belly visibly larger	0
Par. 3; Day 4; Stomach or belly visibly larger	0
Par. 3; Day 5; Stomach or belly visibly larger	0
Par. 3; Day -1; Stomach fullness	0
Par. 3; Day 1; Stomach fullness	0
Par. 3; Day 4; Stomach fullness	0
Par. 3; Day 5; Stomach fullness	0
Par. 3; Day -1; Loss of appetite	0
Par. 3; Day 1; Loss of appetite	0
Par. 3; Day 4; Loss of appetite	0
Par. 3; Day 5; Loss of appetite	0
Par. 3; Day -1; Upper abdominal pain	0
Par. 3; Day 1; Upper abdominal pain	0
Par. 3; Day 4; Upper abdominal pain	0
Par. 3; Day 5; Upper abdominal pain	0
Par. 3; Day -1; Upper abdominal discomfort	0
Par. 3; Day 1; Upper abdominal discomfort	0
Par. 3; Day 4; Upper abdominal discomfort	0
Par. 3; Day 5; Upper abdominal discomfort	0
Par. 3; Day -1; Overall severity of gastroparesis	0
Par. 3; Day 1; Overall severity of gastroparesis	0
Par. 3; Day 4; Overall severity of gastroparesis	0
Par. 3; Day 5; Overall severity of gastroparesis	0
Par. 4; Day -1; Epi of vomiting	0
Par. 4; Day 1; Epi of vomiting	0
Par. 4; Day 4; Epi of vomiting	0
Par. 4; Day 5; Epi of vomiting	0
Par. 4; Day -1; Epi of retching	0
Par. 4; Day 1; Epi of retching	0
Par. 4; Day 4; Epi of retching	0
Par. 4; Day 5; Epi of retching	0
Par. 4; Day -1; Nausea	0
Par. 4; Day 1; Nausea	0
Par. 4; Day 4; Nausea	0
Par. 4; Day 5; Nausea	0
Par. 4; Day -1; Excessively full after meals	0
Par. 4; Day 1; Excessively full after meals	1
Par. 4; Day 4; Excessively full after meals	1
Par. 4; Day 5; Excessively full after meals	0
Par. 4; Day -1; Bloating	0
Par. 4; Day 1; Bloating	1
Par. 4; Day 4; Bloating	0
Par. 4; Day 5; Bloating	0
Par.4; Day -1; Unable to finish normal-sized meal	0
Par.4; Day 1; Unable to finish normal-sized meal	0
Par.4; Day 4; Unable to finish normal-sized meal	0
Par.4; Day 5; Unable to finish normal-sized meal	0
Par. 4; Day -1; Retching	0
Par. 4; Day 1; Retching	0
Par. 4; Day 4; Retching	0
Par. 4; Day 5; Retching	0
Par. 4; Day -1; Vomiting	0
Par. 4; Day 1; Vomiting	0
Par. 4; Day 4; Vomiting	0
Par. 4; Day 5; Vomiting	0
Par. 4; Day -1; Stomach or belly visibly larger	0
Par. 4; Day 1; Stomach or belly visibly larger	0
Par. 4; Day 4; Stomach or belly visibly larger	0
Par. 4; Day 5; Stomach or belly visibly larger	0
Par. 4; Day -1; Stomach fullness	0
Par. 4; Day 1; Stomach fullness	1
Par. 4; Day 4; Stomach fullness	1
Par. 4; Day 5; Stomach fullness	0
Par. 4; Day -1; Loss of appetite	0
Par. 4; Day 1; Loss of appetite	0
Par. 4; Day 4; Loss of appetite	0
Par. 4; Day 5; Loss of appetite	0
Par. 4; Day -1; Upper abdominal pain	0
Par. 4; Day 1; Upper abdominal pain	0
Par. 4; Day 4; Upper abdominal pain	0
Par. 4; Day 5; Upper abdominal pain	0
Par. 4; Day -1; Upper abdominal discomfort	0
Par. 4; Day 1; Upper abdominal discomfort	0
Par. 4; Day 4; Upper abdominal discomfort	0
Par. 4; Day 5; Upper abdominal discomfort	0
Par. 4; Day -1; Overall severity of gastroparesis	0
Par. 4; Day 1; Overall severity of gastroparesis	1
Par. 4; Day 4; Overall severity of gastroparesis	1
Par. 4; Day 5; Overall severity of gastroparesis	0

11. Primary Outcome

Title	Part A: The Volume of Water Ingested During EGG
Description	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.
Time Frame	Up to Day 4

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day 1	430
Par. 1; Day 4	360
Par. 2; Day 1	2160
Par. 2; Day 4	1980
Par. 3; Day 1	900
Par. 3; Day 4	1080
Par. 4; Day 1	1000
Par. 4; Day 4	1000

12. Primary Outcome

Title	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Description	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.
Time Frame	Day 4

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day 4; Pre-WL; Stomach fullness	3
Par. 1; Day 4; 10 minutes Post-WL;Stomach fullness	43
Par. 1; Stomach fullness;Day 4; 20 minutes Post-WL	50
Par. 1; Day 4; 30 minutes Post-WL;Stomach fullness	9
Par. 2; Day 4; Pre-WL;Stomach fullness	11
Par. 2; Day 4; 10 minutes Post-WL;Stomach fullness	94
Par. 2; Day 4; 20 minutes Post-WL;Stomach fullness	92
Par. 2; Day 4; 30 minutes Post-WL;Stomach fullness	85
Par. 3; Day 4; Pre-WL; Stomach fullness	10
Par. 3; Day 4; 10 minutes Post-WL;Stomach fullness	89
Par. 3; Day 4; 20 minutes Post-WL;Stomach fullness	82
Par. 3; Day 4; 30 minutes Post-WL;Stomach fullness	75
Par. 4; Day 4; Pre-WL;Stomach fullness	28
Par. 4; Day 4; 10 minutes Post-WL;Stomach fullness	34
Par. 4; Day 4; 20 minutes Post-WL;Stomach fullness	38
Par. 4; Day 4; 30 minutes Post-WL;Stomach fullness	35
Par. 1; Day 4; Pre-WL; Bloating	4
Par. 1; Day 4; 10 minutes Post-WL;Bloating	27
Par. 1; Day 4; 20 minutes Post-WL;Bloating	46
Par. 1; Day 4; 30 minutes Post-WL; Bloating	45
Par. 2; Day 4; Pre-WL;Bloating	3
Par. 2; Day 4; 10 minutes Post-WL;Bloating	5
Par. 2; Day 4; 20 minutes Post-WL;Bloating	6
Par. 2; Day 4; 30 minutes Post-WL;Bloating	26
Par. 3; Bloating; Day 4; Pre-WL;Bloating	1
Par. 3; Day 4; 10 minutes Post-WL;Bloating	0
Par. 3; Day 4; 20 minutes Post-WL;Bloating	0
Par. 3; Day 4; 30 minutes Post-WL;Bloating	1
Par. 4; Day 4; Pre-WL; Bloating	3
Par. 4; Day 4; 10 minutes Post-WL;Bloating	22
Par. 4; Day 4; 20 minutes Post-WL; Bloating	42
Par. 4; Bloating; Day 4; 30 minutes Post-WL	35
Par. 1; Day 4; Pre-WL; Abdominal pain	3
Par. 1; Day 4; 10 minutes Post-WL; Abdominal pain	4
Par. 1; Day 4; 20 minutes Post-WL; Abdominal pain	3
Par. 1; Day 4; 30 minutes Post-WL;Abdominal pain	3
Par. 2; Day 4; Pre-WL; Abdominal pain	4
Par. 2; Day 4; 10 minutes Post-WL; Abdominal pain	4
Par. 2; Day 4; 20 minutes Post-WL; Abdominal pain	7
Par. 2; Day 4; 30 minutes Post-WL;Abdominal pain	6
Par. 3; Day 4; Pre-WL; Abdominal pain	0
Par. 3;Day 4; 10 minutes Post-WL; Abdominal pain	0
Par. 3; Day 4; 20 minutes Post-WL; Abdominal pain	0
Par. 3; Day 4; 30 minutes Post-WL; Abdominal pain	0
Par. 4; Day 4; Pre-WL; Abdominal pain	4
Par. 4; Day 4; 10 minutes Post-WL;Abdominal pain	4
Par. 4; Day 4; 20 minutes Post-WL; Abdominal pain	5
Par. 4; Day 4; 30 minutes Post-WL; Abdominal pain	5
Par. 1; Day 4; Pre-WL; Hunger	88
Par. 1; Day 4; 10 minutes Post-WL; Hunger	79
Par. 1; Day 4; 20 minutes Post-WL;Hunger	85
Par. 1;Day 4; 30 minutes Post-WL;Hunger	84
Par. 2; Day 4; Pre-WL;Hunger	32
Par. 2; Day 4; 10 minutes Post-WL; Hunger	16
Par. 2; Day 4; 20 minutes Post-WL; Hunger	19
Par. 2; Day 4; 30 minutes Post-WL; Hunger	27
Par. 3; Day 4; Pre-WL; Hunger	21
Par. 3; Day 4; 10 minutes Post-WL; Hunger	3
Par. 3; Day 4; 20 minutes Post-WL; Hunger	6
Par. 3; Day 4; 30 minutes Post-WL;Hunger	17
Par. 4; Day 4; Pre-WL;Hunger	19
Par. 4; Day 4; 10 minutes Post-WL; Hunger	16
Par. 4; Day 4; 20 minutes Post-WL; Hunger	29
Par. 4; Day 4; 30 minutes Post-WL;Hunger	37

13. Primary Outcome

Title	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Description	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.
Time Frame	Up to 12 days

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day -1; SBP	126
Par. 1; Day 1; SBP	121
Par. 1; Day 4; SBP	124
Par. 1; Day 5; SBP	112
Par. 1; Follow-up; SBP	125
Par. 1; Day -1; DBP	71
Par. 1; Day 1; DBP	61
Par. 1; Day 4; DBP	69
Par. 1; Day 5; DBP	67
Par. 1; Follow-up; DBP	72
Par. 2; Day -1; SBP	105
Par. 2; Day 1; SBP	109
Par. 2; Day 4; SBP	119
Par. 2; Day 5; SBP	121
Par. 2; Follow-up; SBP	124
Par. 2; Day -1; DBP	61
Par. 2; Day 1; DBP	68
Par. 2; Day 4; DBP	71
Par. 2; Day 5; DBP	68
Par. 2; Follow-up; DBP	75
Par. 3; Day -1; SBP	131
Par. 3; Day 1; SBP	131
Par. 3; Day 4; SBP	132
Par. 3; Day 5; SBP	112
Par. 3; Follow-up; SBP	126
Par. 3; Day -1; DBP	86
Par. 3; Day 1; DBP	82
Par. 3; Day 4; DBP	87
Par. 3; Day 5; DBP	76
Par. 3; Follow-up; DBP	87
Par. 4; Day -1; SBP	138
Par. 4; Day 1; SBP	139
Par. 4; Day 4; SBP	127
Par. 4; Day 5; SBP	123
Par. 4; Follow-up; SBP	160
Par. 4; Day -1; DBP	83
Par. 4; Day 1; DBP	90
Par. 4; Day 4; DBP	83
Par. 4; Day 5; DBP	81
Par. 4; Follow-up; DBP	86

14. Primary Outcome

Title	Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Description	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.
Time Frame	Up to 12 days

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Day -1	69
Par. 1; Day 1	65
Par. 1; Day 4	66
Par. 1; Day 5	84
Par. 1; Follow-up	68
Par. 2; Day -1	57
Par. 2; Day 1	64
Par. 2; Day 4	62
Par. 2; Day 5	82
Par. 2; Follow-up	58
Par. 3; Day -1	72
Par. 3; Day 1	74
Par. 3; Day 4	78
Par. 3; Day 5	82
Par. 3; Follow-up	78
Par. 4; Day -1	78
Par. 4; Day 1	89
Par. 4; Day 4	77
Par. 4; Day 5	82
Par. 4; Follow-up	72

15. Primary Outcome

Title	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par.1; Basophils	0.02
Par.1; Eosinophils	0.11
Par.1; Lymphocytes	1.57
Par.1; Monocytes	0.35
Par.1; Platelet count	268
Par.1; Total Neutrophils	6.33
Par.1; WBC	8.4
Par.2; Basophils	0.02
Par.2; Eosinophils	0.04
Par.2; Lymphocytes	1.39
Par.2; Monocytes	0.25
Par.2; Platelet count	217
Par.2; Total Neutrophils	2.54
Par.2; WBC	4.2
Par.3; Basophils	0.03
Par.3; Eosinophils	0.21
Par.3; Lymphocytes	1.77
Par.3; Monocytes	0.58
Par.3; Platelet count	202
Par.3; Total Neutrophils	5.09
Par.3; WBC	7.7
Par.4; Basophils	0.04
Par.4; Eosinophils	0.23
Par.4; Lymphocytes	3.06
Par.4; Monocytes	0.89
Par.4; Platelet count	230
Par.4; Total Neutrophils	1.2
Par.4; WBC	5.4

16. Primary Outcome

Title	Part A: Red Blood Cell (RBC) Count at Indicated Time Points
Description	Blood samples were collected for analysis of RBC count. Individual Par. data at indicated time point has been presented.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1	4.7
Par. 2	4.8
Par. 3	5
Par. 4	4.9

17. Primary Outcome

Title	Part A: Hemoglobin Level at Indicated Time Points
Description	Blood samples were collected for analysis of hemoglobin level. Individual Par. data at indicated time point has been presented.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1	125
Par. 2	133
Par. 3	149
Par. 4	156

18. Primary Outcome

Title	Part A: Hematocrit Level at Indicated Time Points
Description	Blood samples were collected for analysis of hematocrit level. Individual Par. data at indicated time points has been presented.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1	0.399
Par. 2	0.426
Par. 3	0.466
Par. 4	0.462

19. Primary Outcome

Title	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; ALT	21
Par. 1; AST	20
Par. 1; GGT	46
Par. 2; ALT	25
Par. 2; AST	18
Par. 2; GGT	76
Par. 3; ALT	11
Par. 3; AST	12
Par. 3; GGT	19
Par. 4; ALT	17
Par. 4; AST	20
Par. 4; GGT	30

20. Primary Outcome

Title	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Glucose	9.2
Par. 1; Calcium	2.44
Par. 1; Magnesium	0.86
Par. 1; Potassium	5.6
Par. 1; Sodium	139
Par. 1; Phosphorus inorganic	1.5
Par. 1; Chloride	105
Par. 1; Urea/BUN	7.5
Par. 2; Glucose	7.5
Par. 2; Calcium	2.44
Par. 2; Magnesium	0.9
Par. 2; Potassium	5.1
Par. 2; Sodium	139
Par. 2; Phosphorus inorganic	1.25
Par. 2; Chloride	105
Par. 2; Urea/BUN	6.5
Par. 3; Glucose	9.1
Par. 3; Calcium	2.38
Par. 3; Magnesium	0.8
Par. 3; Potassium	4.2
Par. 3; Sodium	140
Par. 3; Phosphorus inorganic	1.2
Par. 3; Chloride	103
Par. 3; Urea/BUN	7
Par. 4; Glucose	7.9
Par. 4; Calcium	2.4
Par. 4; Magnesium	0.8
Par. 4; Potassium	4.3
Par. 4; Sodium	138
Par. 4; Phosphorus inorganic	1.15
Par. 4; Chloride	101
Par. 4; Urea/BUN	4.5

21. Primary Outcome

Title	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Creatinine	67.2
Par. 1; Direct Bilirubin	2
Par. 1; Total Bilirubin	10
Par. 1; Indirect Bilirubin	8
Par. 2; Creatinine	105.2
Par. 2; Direct Bilirubin	2
Par. 2; Total Bilirubin	6
Par. 2; Indirect Bilirubin	4
Par. 3; Creatinine	76.9
Par. 3; Direct Bilirubin	4
Par. 3; Total Bilirubin	16
Par. 3; Indirect Bilirubin	12
Par. 4; Creatinine	83.1
Par. 4; Direct Bilirubin	2
Par. 4; Total Bilirubin	6
Par. 4; Indirect Bilirubin	4

22. Primary Outcome

Title	Part A: Estimated Glomerular Filtration Rate at Indicated Time Points
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Part. 1	1.3026
Part. 2	1.2859
Part. 3	1.5197
Part. 4	1.6533

23. Primary Outcome

Title	Part A: Total Protein, Albumin Levels at Indicated Time Points
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Total Protein	77
Par. 1; Albumin levels	43
Par. 2; Total Protein	75
Par. 2; Albumin levels	46
Par. 3; Total Protein	71
Par. 3; Albumin levels	44
Par. 4; Total Protein	74
Par. 4; Albumin levels	46

24. Primary Outcome

Title	Part A: Albumin Level in Urine at Indicated Time Points
Description	Samples were collected to analyze albumin level in urine. Individual Par. data at indicated time point has been collected.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1	35
Par. 2	35
Par. 3	5
Par. 4	5

25. Primary Outcome

Title	Part A: Concentration of Creatinine in Urine at Indicated Time Points
Description	Samples were collected to analyze concentration of creatinine in urine. Individual Par. at indicated time point has been presented at indicated time points.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1	12450
Par. 2	16240
Par. 3	13300
Par. 4	22020

26. Primary Outcome

Title	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1; Ketones; Negative	1 25%
Par 1; Occult blood; Trace	1 25%
Par 1; Glucose	NA NaN
Par 1; Nitrates	NA NaN
Par 1; Leukocyte esterase	NA NaN
Par. 2; Ketones; Negative	1 25%
Par. 2; Occult blood; Negative	1 25%
Par. 2; Glucose	NA NaN
Par 2; Nitrates	NA NaN
Par 2; Leukocyte esterase	NA NaN
Par. 3; Ketones; Negative	1 25%
Par. 3; Occult blood; Negative	1 25%
Par. 3; Glucose	NA NaN
Par 3; Nitrates	NA NaN
Par 3; Leukocyte esterase	NA NaN
Par. 4; Ketones; Negative	1 25%
Par. 4; Occult blood; Negative	1 25%
Par. 4; Glucose	NA NaN
Par 4; Nitrates	NA NaN
Par 4; Leukocyte esterase	NA NaN

27. Primary Outcome

Title	Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par.1; RBC	1
Par. 1; WBC	1
Par. 2; RBC	NA
Par. 2; WBC	NA
Par. 3; RBC	NA
Part. 3; WBC	NA
Part 4; RBC	NA
Part. 4; WBC	NA

28. Primary Outcome

Title	Part A: Specific Gravity of Urine at Indicated Time Points
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1	1.021
Par. 2	1.019
Par. 3	1.023
Par. 4	1.027

29. Primary Outcome

Title	Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Par. 1	5
Par. 2	5.5
Par. 3	6
Par. 4	5

30. Primary Outcome

Title	Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)
Description	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.
Time Frame	Up to 12 days

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Any AE	1 25%
Any SAE	0 0%

31. Primary Outcome

Title	Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD
Description	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.
Time Frame	Up to 12 days

Outcome Measure Data

Analysis Population Description

All Subjects Population.

Arm/Group Title	Part A: Exenatide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
Measure Participants	4
Number [Participants]	0 0%

32. Primary Outcome

Title	Part B: Distribution of Average Power by Frequency Region
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

33. Primary Outcome

Title	Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

34. Primary Outcome

Title	Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

35. Primary Outcome

Title	Part B: Assessment of Nausea by VAS Score
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

36. Secondary Outcome

Title	Part B: Time to Half-gastric Emptying
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

37. Secondary Outcome

Title	Part B: Rate of [13]C Dose Excreted in Breath
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

38. Secondary Outcome

Title	Part B: The Volume of Water Ingested During EGG
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

39. Secondary Outcome

Title	Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

40. Secondary Outcome

Title	Part B: Number of Par. With Abnormal Values for Vital Signs
Description	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.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

41. Secondary Outcome

Title	Part B: Number of Par. With Abnormal Values for Hematology Parameters
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

42. Secondary Outcome

Title	Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

43. Secondary Outcome

Title	Part B: Number of Par. With Abnormal Values for Urinalysis
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

44. Secondary Outcome

Title	Part B: Number of Par. With AEs and SAEs
Description	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.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

45. Secondary Outcome

Title	Part B: Assessment of GCSI-DD Score
Description	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.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

46. Secondary Outcome

Title	Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD
Description	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.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Part B: Exenatide SC Injection	Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
Measure Participants	0	0

Adverse Events

Time Frame	On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
Adverse Event Reporting Description	AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
Arm/Group Title	Part A: Exenatide SC Injection		Part B: Exenatide SC Injection		Part B: Albiglutide SC Injection
Arm/Group Description	Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.		Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.		Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
All Cause Mortality
	Part A: Exenatide SC Injection		Part B: Exenatide SC Injection		Part B: Albiglutide SC Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Part A: Exenatide SC Injection		Part B: Exenatide SC Injection		Part B: Albiglutide SC Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Part A: Exenatide SC Injection		Part B: Exenatide SC Injection		Part B: Albiglutide SC Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		0/0 (NaN)		0/0 (NaN)
Gastrointestinal disorders
Abdominal distension	1/4 (25%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Diarrhoea	1/4 (25%)	1	0/0 (NaN)	1	0/0 (NaN)	1
General disorders
Early satiety	1/4 (25%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Feeling jittery	1/4 (25%)	1	0/0 (NaN)	1	0/0 (NaN)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.