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 |
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
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