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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Renal Impairment
• Interventions: Drug: LX4211; Drug: LX4211 Placebo

• Registration Number: NCT01555008
• Lead Sponsor: Lexicon Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Primary Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A	LX4211	-
LX4211 Placebo	LX4211 Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in postprandial glucose	baseline to 7 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 Renton, Washington, United States