Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
NCT ID: NCT01555008
Last Updated: 2013-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment A
LX4211
Subjects will receive LX4211 once daily for 7 days
LX4211 Placebo
LX4211 Placebo
Subjects will receive LX4211 placebo once daily for 7 days
Interventions
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LX4211
Subjects will receive LX4211 once daily for 7 days
LX4211 Placebo
Subjects will receive LX4211 placebo once daily for 7 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Ike Ogbaa, M.D.
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Anniston, Alabama, United States
Lexicon Investigational Site
Chula Vista, California, United States
Lexicon Investigational Site
Edgewater, Florida, United States
Lexicon Investigational Site
Minneapolis, Minnesota, United States
Lexicon Investigational Site
San Antonio, Texas, United States
Lexicon Investigational Site
Renton, Washington, United States
Countries
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References
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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.
Zambrowicz 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.
Other Identifiers
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LX4211.107
Identifier Type: OTHER
Identifier Source: secondary_id
LX4211.1-107-DM
Identifier Type: -
Identifier Source: org_study_id