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

Completed · Phase 1 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Renal Impairment

In brief

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.

Key facts

Study ID

NCT01555008

Run by

Lexicon Pharmaceuticals

People needed

31

Starts

2012-03-01

Last updated by the study team

2013-09-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lexicon Investigational Site — Anniston, Alabama, United States
• Lexicon Investigational Site — Chula Vista, California, United States
• Lexicon Investigational Site — Edgewater, Florida, United States
• Lexicon Investigational Site — Minneapolis, Minnesota, United States
• Lexicon Investigational Site — San Antonio, Texas, United States
• Lexicon Investigational Site — Renton, Washington, United States

Full record on ClinicalTrials.gov

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