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

Lexicon Pharmaceuticals1 site in 1 country31 target enrollmentMarch 2012

ConditionsType 2 Diabetes Mellitus Renal Impairment

InterventionsLX4211 LX4211 Placebo

DrugsLX4211 LX4211 Placebo

Overview

Phase: Phase 1
Intervention: LX4211
Conditions: Type 2 Diabetes Mellitus
Sponsor: Lexicon Pharmaceuticals
Enrollment: 31
Locations: 1
Primary Endpoint: Change from baseline in postprandial glucose
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

August 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lexicon Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Treatment A

Intervention: LX4211

LX4211 Placebo

Intervention: LX4211 Placebo

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)