Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Investigator Identifier
Stratification Factor 1
Stratification Factor 1 Numeric Code
Stratification Factor 2
Stratification Factor 2 Numeric Code
Sex Numeric Code
Race Numeric Code
Planned Arm Code
Description of Planned Arm
Planned Arm Number
Actually Received Arm Code
Description of Actually Received Arm
Actually Received Arm Number
Randomized Population
Safety Population
Completers Population
Exposed Population
Intent-to-treat Population
Subject Reference Start Date
Subject Reference Start Date (Char)
Subject Reference End Date
Subject Reference End Date (Char)
Treatment End Date/Time
Treatment End Date
Treatment End Date (Char)
Country Name
Study Site Identifier
Center Identifier
Investigator Name
Race Other
Ethnicity
Date of Birth
Date of Birth (Char)
Run-in Population
End of Treatment Flag
End of Treatment Reason
End of Treatment Reason Numeric Code
End of Treatment Reason Other Comment
End of Treatment Subject Decision
Broken Code
Broken Code Reason
Age Group
Age Group Numeric Code
Age Group for Dem Table
Age Group for Dem Table Num Code
Screening Height (cm)
Baseline Height (cm)
Screening Weight (kg)
Baseline Weight (kg)
Screening BMI (kg/m2)
Screening BMI Group
Screening BMI Group Numeric Code
Baseline BMI (kg/m2)
Baseline BMI Group
Baseline BMI Group Numeric Code
Screening HbA1c (%)
Screening HbA1c Group
Screening HbA1c Group Numeric Code
Baseline HbA1c (%)
Baseline FPG (mmol/L)
Bsln 2-hr Postprandial Glucose (mmol/L)
Bsln Postprandial Glu Excursion (mmol/L)
Bsln Fasting Plasma Insulin (pmol/L)
Bsln 2-hr Postprandial Insulin (pmol/L)
Bsln Pre-injection Glucagon (ng/L)
Bsln 2-hr Postprandial Glucagon (ng/L)
Bsln Pre-injection Proinsulin (pmol/L)
Bsln 2-hr Postprand. Proinsulin (pmol/L)
Bsln Pre-injection C-peptide (nmol/L)
Bsln 2-hr Postprand. C-peptide (nmol/L)
Bsln Pre-injection Proins/Ins Ratio
Bsln 2-hr Postprandial Proins/Ins Ratio
Baseline HOMA Beta-Cell Function Index
Baseline HOMA Insulin Resistance Index
Baseline Microalbuminuria Group
Baseline Microalbuminuria Subgroup
Screening Creatinine Clearance (ml/min)
Screening Creatinine Clearance Group
End of Study Date
End of Study Date (Char)
Consent Date
Consent Date (Char)
Randomization Date
Randomization Date (Char)
Analysis Day of Study Participation
Death Date
Death Occurrence on Treatment
Death Occurrence on Treatment Flag
Death Occurrence Period
Death Occurrence Period Flag
Duration of Diabetes (years)
Age at Onset of Diabetes (years)
History of Gestational Diabetes
Subject Took GLP-1 Agonist
Subject Had Diabetic Retinopathy
Subj Had Diab Sensory/Motor Neuropathy
Subj. Had Diabetic Autonomic Neuropathy
Subject Had Diabetic Nephropathy
Most Recent Nephropathic Event at Scrng
Most Recnt Nephro Evnt at Scrng Num Code
Pharmacokinetic Population
Rescued Population
Date of Start of Rescue Therapy
Study Day of Start of Rescue Therapy
Duration of Metformin Treatment (years)
Baseline Metformin Daily Dose (mg/day)
Baseline Metformin Daily Dose Group
Lixi Antibody Status Over Whole Trt Prd
Baseline albumin/Creatinine ratio Group