NCT01555008CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Lexicon Pharmaceuticals
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change from baseline in postprandial glucose
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment A
Experimental
Intervention: LX4211 (Drug)
LX4211 Placebo
Placebo Comparator
Intervention: LX4211 Placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline in postprandial glucose
Time Frame: baseline to 7 days
Secondary Outcomes
- Number of subjects experiencing an adverse event(7 days)
- Change from baseline in fasting plasma glucose(baseline to 7 days)
- Change from baseline in glucagon-like peptide 1 (Glp-1)(baseline to 7 days)
- Area Under Curve (AUC)(Days 1 and 7; predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
Investigators
Study Sites (1)
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