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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01555008
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : September 9, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Renal Impairment Drug: LX4211 Drug: LX4211 Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in postprandial glucose [ Time Frame: baseline to 7 days ]

Secondary Outcome Measures :
  1. Number of subjects experiencing an adverse event [ Time Frame: 7 days ]
  2. Change from baseline in fasting plasma glucose [ Time Frame: baseline to 7 days ]
  3. Change from baseline in glucagon-like peptide 1 (Glp-1) [ Time Frame: baseline to 7 days ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01555008

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United States, Alabama
Lexicon Investigational Site
Anniston, Alabama, United States, 36207
United States, California
Lexicon Investigational Site
Chula Vista, California, United States, 91911
United States, Florida
Lexicon Investigational Site
Edgewater, Florida, United States, 32132
United States, Minnesota
Lexicon Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, Texas
Lexicon Investigational Site
San Antonio, Texas, United States, 78209
United States, Washington
Lexicon Investigational Site
Renton, Washington, United States, 98057
Sponsors and Collaborators
Lexicon Pharmaceuticals
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Study Director: Ike Ogbaa, M.D. Lexicon Pharmaceuticals, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lexicon Pharmaceuticals Identifier: NCT01555008     History of Changes
Other Study ID Numbers: LX4211.1-107-DM
LX4211.107 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Renal Insufficiency
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs