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Diabetes Mellitus, Type 2Phase 4NCT02793154

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

A Phase 4 study testing Exenatide and Albiglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Exenatide and Albiglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesUnited States
Study dates
26 Sep 2016to 16 Mar 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Louisville, Kentucky, 40213

Other trials in United States

About this study

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

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.

Being tested
Exenatide, Albiglutide
Keywords
gastric emptying, albiglutide, GMA, exenatide, type 2 diabetes mellitus
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExenatideDrug

    Also called Byetta

    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)

  • AlbiglutideDrug

    Also called Tanzeum in US

    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

Study groups in NCT02793154
Study groupRoleWhat they receive
Part A: ExenatideExperimentalPart A is a single arm design and all subjects will receive 10 mcg subcutaneous injection (SC) of exenatide twice daily for 5 days
Receives: Drug: Exenatide
Part B: AlbiglutideExperimentalIn 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
Receives: Drug: Albiglutide
Part B: ExenatideActive comparatorIn 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
Receives: Drug: Exenatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Distribution of Average Power by Frequency Region

    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.

    Measured: Up to Day 4

  2. Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region

    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.

    Measured: Up to Day 4

  3. Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal

    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.

    Measured: Up to Day 4

  4. Part A: Number of Par. With Shifts in Gastric Rhythm Status

    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.

    Measured: Up to 12 days

  5. Part A: Number Par. by Gastric Rhythm Status

    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.

    Measured: Up to 12 days

  6. Part A: Average Dominant Frequency

    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.

    Measured: Up to Day 4

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

    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.

    Measured: Day 4

  8. Part A: Time to Half-gastric Emptying

    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.

    Measured: Up to Day 5

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

    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.

    Measured: Day 5

  10. Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score

    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.

    Measured: Up to Day 5

  11. Part A: The Volume of Water Ingested During EGG

    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.

    Measured: Up to Day 4

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

    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.

    Measured: Day 4

  13. Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety

    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.

    Measured: Up to 12 days

  14. Part A: Assessment of Heart Rate (HR) as a Measure of Safety

    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.

    Measured: Up to 12 days

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

    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.

    Measured: Day 5

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

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

    Measured: Day 5

  17. Part A: Hemoglobin Level at Indicated Time Points

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

    Measured: Day 5

  18. Part A: Hematocrit Level at Indicated Time Points

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

    Measured: Day 5

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

    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.

    Measured: Day 5

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

    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.

    Measured: Day 5

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

    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.

    Measured: Day 5

  22. Part A: Estimated Glomerular Filtration Rate at Indicated Time Points

    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.

    Measured: Day 5

  23. Part A: Total Protein, Albumin Levels at Indicated Time Points

    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.

    Measured: Day 5

  24. Part A: Albumin Level in Urine at Indicated Time Points

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

    Measured: Day 5

  25. Part A: Concentration of Creatinine in Urine at Indicated Time Points

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

    Measured: Day 5

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

    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.

    Measured: Day 5

  27. Part A: Presence RBC and WBC in Urine Assessed by Microscopy

    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.

    Measured: Day 5

  28. Part A: Specific Gravity of Urine at Indicated Time Points

    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.

    Measured: Day 5

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

    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.

    Measured: Day 5

  30. Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)

    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.

    Measured: Up to 12 days

  31. Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD

    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.

    Measured: Up to 12 days

  32. Part B: Distribution of Average Power by Frequency Region

    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.

    Measured: Up to 8 weeks

  33. Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region

    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.

    Measured: Up to 8 weeks

  34. Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal

    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.

    Measured: Up to 8 weeks

  35. Part B: Assessment of Nausea by VAS Score

    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.

    Measured: Up to 8 weeks

Secondary outcomes (11)

  1. Part B: Time to Half-gastric Emptying

    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.

    Measured: Up to 8 weeks

  2. Part B: Rate of [13]C Dose Excreted in Breath

    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.

    Measured: Up to 8 weeks

  3. Part B: The Volume of Water Ingested During EGG

    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.

    Measured: Up to 8 weeks

  4. Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score

    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.

    Measured: Up to 8 weeks

  5. Part B: Number of Par. With Abnormal Values for Vital Signs

    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.

    Measured: Up to 12 weeks

  6. Part B: Number of Par. With Abnormal Values for Hematology Parameters

    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.

    Measured: Up to 8 weeks

  7. Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters

    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.

    Measured: Up to 8 weeks

  8. Part B: Number of Par. With Abnormal Values for Urinalysis

    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.

    Measured: Up to 8 weeks

  9. Part B: Number of Par. With AEs and SAEs

    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.

    Measured: Up to 12 weeks

  10. Part B: Assessment of GCSI-DD Score

    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.

    Measured: Up to 8 weeks

  11. Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD

    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.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2016 (estimated)
  2. Study start26 Sep 2016
  3. Primary completion16 Mar 2017
  4. Study completion16 Mar 2017

Why it stopped: Early termination due to insufficient enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02793154
Sponsor's protocol ID
204879
Status last verified
Oct 2020
First submitted
16 May 2016
Last updated
30 Oct 2020
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Exenatide and Albiglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Distribution of Average Power by Frequency Region (time frame: Up to Day 4). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02793154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.

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