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

Lexicon Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Renal Impairment

Type 2 Diabetes Mellitus

Treatments

Drug: LX4211 Placebo

Drug: LX4211

Study type

Interventional

Funder types

Industry

Identifiers

NCT01555008

LX4211.1-107-DM

LX4211.107 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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