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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:11/30/-0001
Start Date:March 2012
Contact:Anne Turnage
Email:aturnage@lexpharma.com
Phone:(281) 863-3740

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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes Mellitus and Moderate to Severe Renal Impairment


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.


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
We found this trial at
5
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Minneapolis, Minnesota 55404
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Anaheim, California 92801
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Boynton Beach, Florida 33426
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Huntsville, Alabama 35801
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San Antonio, Texas 78209
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San Antonio, TX
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