A Double-blind [Sponsor Unblinded], Randomized, Placebo-controlled, Staggered-parallel Study to Investigate the Safety, Tolerability, and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

Registration

Registration

NCT01725126

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

DOUBLE

Status

COMPLETED

Enrollment

53

Start

2013-02-10

Primary completion

2013-09-12

Lead sponsor

GlaxoSmithKline

Conditions

Obesity

Interventions

DRUG:GSK2890457; DRUG:Metformin; DRUG:Placebo; DRUG:Liraglutide

Results posted

TRUE

Individual participant data sharing

YES

Registered primary outcomes

• Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A [Up to Follow-up (8 weeks)]
• Number of Participants With Any AE, SAE or Death During Part B and Part C [Up to Follow-up (8 weeks)]
• Number of Participants With Any Hypoglycemic Events During Part A [Up to Follow-up (8 weeks)]
• Number of Participants With Any Hypoglycemic Events During Part B and Part C [Up to Follow-up (8 weeks)]
• Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study [Baseline (Day -1) and Day 42]
• Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) and Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) and Day 42]
• Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A [Up to Day 42]
• Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B [Up to Day 42]
• Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C [Up to Day 42]
• Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A [Up to Day 42]
• Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C [Up to Day 42]
• Mean pH Values of Urine During the Double-blind Treatment Period of Part A [up to Day 42]
• Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C [Up to Day 42]
• Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Day 42]
• Change From Baseline in Electrocardiogram (ECG) Intervals During Part A [Baseline (Day 1, Randomization) up to Follow-up (Day 56)]
• Change From Baseline in ECG Intervals During Part B and C [Baseline (Day -1) up to Follow-up (Day 56)]
• Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A [Baseline (Day 1, Randomization) up to Day 42]
• Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C [Baseline (Day -2) up to Day 41]
• Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C [Baseline (Day -1 and Day 1) up to Day 42]
• Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C [Baseline (Day -1 and Day 1) up to Day 42]
• Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) and Day 42]
• Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) and Day 42 of Part B and C]
• Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) and Day 42]
• Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) and Day 42]
• Change From Baseline in Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) and Day 42]
• Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C [Baseline (Day -1) and Day 42]
• Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C [Baseline (Day -1) up to Follow-up (Day 56)]