Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
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
2 other identifiers
interventional
31
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedSeptember 9, 2013
September 1, 2013
1.4 years
March 7, 2012
September 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in postprandial glucose
baseline to 7 days
Secondary Outcomes (4)
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
Study Arms (2)
Treatment A
EXPERIMENTALLX4211 Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Lexicon Investigational Site
Anniston, Alabama, 36207, United States
Lexicon Investigational Site
Chula Vista, California, 91911, United States
Lexicon Investigational Site
Edgewater, Florida, 32132, United States
Lexicon Investigational Site
Minneapolis, Minnesota, 55404, United States
Lexicon Investigational Site
San Antonio, Texas, 78209, United States
Lexicon Investigational Site
Renton, Washington, 98057, United States
Related Publications (2)
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVEDZambrowicz B, Lapuerta P, Strumph P, Banks P, Wilson A, Ogbaa I, Sands A, Powell D. LX4211 therapy reduces postprandial glucose levels in patients with type 2 diabetes mellitus and renal impairment despite low urinary glucose excretion. Clin Ther. 2015 Jan 1;37(1):71-82.e12. doi: 10.1016/j.clinthera.2014.10.026. Epub 2014 Dec 17.
PMID: 25529979DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ike Ogbaa, M.D.
Lexicon Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 15, 2012
Study Start
March 1, 2012
Primary Completion
August 1, 2013
Last Updated
September 9, 2013
Record last verified: 2013-09