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

Registration

Registration

NCT02793154

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE4

Masking

NONE

Status

TERMINATED

Enrollment

4

Start

2016-09-26

Primary completion

2017-03-16

Lead sponsor

GlaxoSmithKline

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG:Exenatide; DRUG:Albiglutide

Results posted

TRUE

Individual participant data sharing

NO

Registered primary outcomes

• Part A: Distribution of Average Power by Frequency Region [Up to Day 4]
• Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region [Up to Day 4]
• 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]
• Part A: Number of Par. With Shifts in Gastric Rhythm Status [Up to 12 days]
• Part A: Number Par. by Gastric Rhythm Status [Up to 12 days]
• Part A: Average Dominant Frequency [Up to Day 4]
• Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score [Day 4]
• Part A: Time to Half-gastric Emptying [Up to Day 5]
• Part A: Rate of [13]C Dose Excreted in Breath [Day 5]
• Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score [Up to Day 5]
• Part A: The Volume of Water Ingested During EGG [Up to Day 4]
• Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score [Day 4]
• Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety [Up to 12 days]
• Part A: Assessment of Heart Rate (HR) as a Measure of Safety [Up to 12 days]
• Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points [Day 5]
• Part A: Red Blood Cell (RBC) Count at Indicated Time Points [Day 5]
• Part A: Hemoglobin Level at Indicated Time Points [Day 5]
• Part A: Hematocrit Level at Indicated Time Points [Day 5]
• Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points [Day 5]
• Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels [Day 5]
• Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points [Day 5]
• Part A: Estimated Glomerular Filtration Rate at Indicated Time Points [Day 5]
• Part A: Total Protein, Albumin Levels at Indicated Time Points [Day 5]
• Part A: Albumin Level in Urine at Indicated Time Points [Day 5]
• Part A: Concentration of Creatinine in Urine at Indicated Time Points [Day 5]
• Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points [Day 5]
• Part A: Presence RBC and WBC in Urine Assessed by Microscopy [Day 5]
• Part A: Specific Gravity of Urine at Indicated Time Points [Day 5]
• Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points [Day 5]
• Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs) [Up to 12 days]
• Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD [Up to 12 days]
• Part B: Distribution of Average Power by Frequency Region [Up to 8 weeks]
• Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region [Up to 8 weeks]
• 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]
• Part B: Assessment of Nausea by VAS Score [Up to 8 weeks]