Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lexicon Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult subjects between the ages of 18 to 75 years, inclusive
Confirmed diagnosis of Type 2 diabetes mellitus
Meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dL
Stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks
Willing and able to provide written informed consent
Willing and able to maintain consistent dietary, physical activity, and sleeping patterns throughout the study
You may not be if
History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
History of renal disease or clinically significant abnormal kidney function tests
Presence of active hepatic disease or clinically significant abnormal liver function tests
Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day 1
History of clinically significant cardiac arrhythmias within one year of study Day 1
Subjects with congestive heart failure
Subjects with uncontrolled Stage III hypertension
Triglycerides \>1000 mg/dL at Screening
Known history of HIV or hepatitis C
History of illicit drug or alcohol abuse with one year of study Day 1
Have had 2 or more emergency room visits, doctor visits, or hospitalizations due to hypoglycemia within 6 months of study Day 1
Use of any other investigational drug within 30 days of study Day 1
Prior exposure to LX4211
Use of any medication or herbal supplement for the purpose of weight loss
Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study Day 1
Use of corticosteroids within 2 weeks prior to study Day 1
Major surgery within 6 months of study Day 1
Subjects with any history of severe gastroparesis
Inability or difficulty swallowing whole capsules or tablets
Women who are pregnant or breast feeding
Clareo Health | Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
