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

This study is currently recruiting participants.
Verified May 2013 by Lexicon Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01555008
First received: March 7, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Renal Impairment
 Drug: LX4211
Drug: LX4211 Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in postprandial glucose [ Time Frame: baseline to 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects experiencing an adverse event [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in fasting plasma glucose [ Time Frame: baseline to 7 days ] [ Designated as safety issue: No ]
  • Change from baseline in glucagon-like peptide 1 (Glp-1) [ Time Frame: baseline to 7 days ] [ Designated as safety issue: No ]
  • Area Under Curve (AUC) [ Time Frame: Days 1 and 7; predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: LX4211
Subjects will receive LX4211 once daily for 7 days
Placebo Comparator: LX4211 Placebo Drug: LX4211 Placebo
Subjects will receive LX4211 placebo once daily for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555008

Contacts
Contact: Anne Turnage (281) 863-3740 aturnage@lexpharma.com

Locations
United States, Alabama
Lexicon Investigational Site Recruiting
Anniston, Alabama, United States, 36207
United States, California
Lexicon Investigational Site Recruiting
Chula Vista, California, United States, 91911
United States, Florida
Lexicon Investigational Site Recruiting
Edgewater, Florida, United States, 32132
United States, Minnesota
Lexicon Investigational Site Recruiting
Minneapolis, Minnesota, United States, 55404
United States, Texas
Lexicon Investigational Site Recruiting
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Ike Ogbaa, M.D. Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01555008     History of Changes
Other Study ID Numbers: LX4211.1-107-DM, LX4211.107
Study First Received: March 7, 2012
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013