Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Criteria

Inclusion Criteria:

• Adults ≥18 to ≤80 years of age

• History of T2DM for at least 6 months prior to screening

• Moderate to severe renal impairment and not actively on dialysis

• Willing and able to perform self-monitoring of blood glucose

• Willing and able to provide written informed consent

Exclusion Criteria:

• History of type 1 diabetes mellitus, diabetic ketoacidosis (within the previous 6 months), or diabetes resulting from pancreatic disorder or secondary diabetes (from acromegaly and/or Cushing's disease)

• Subjects who have received a renal allograft

• Subjects expecting to require dialysis or to undergo kidney transplantation within 3 months of study dosing

• Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or planned study Day -1

• Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day -2

• History of clinically significant cardiac arrhythmias within 1 year prior to study Day -2

• Subjects with congestive heart failure

• Subjects with uncontrolled Stage III hypertension

• History of 2 or more emergency room visits, doctors' visits, or hospitalizations due to hypoglycemia within the 6 months prior to planned study Day -2

• History of alcohol or illicit drug abuse within 1 year prior to Screening

• History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

• Major surgery within 6 months prior to planned study Day -2

• History of any malignancy within the last 5 years

• Triglycerides >1000 mg/dL at Screening or planned study Day -1

• History of any serious adverse reaction or hypersensitivity to an SGLT inhibitor

• Use of corticosteroids within 2 weeks prior to study Day 1

• Use of any investigational drug within 30 days prior to study Day 1, or investigational protein or antibodies within 60 days of Day 1

• Positive urine pregnancy test at Screening

• Positive urine screen for illicit drug abuse at Screening

• Prior exposure to LX4211