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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01555008
First received: March 7, 2012
Last updated: September 6, 2013
Last verified: September 2013

March 7, 2012
September 6, 2013
March 2012
August 2013   (final data collection date for primary outcome measure)
Change from baseline in postprandial glucose [ Time Frame: baseline to 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01555008 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Renal Impairment
  • Drug: LX4211
    Subjects will receive LX4211 once daily for 7 days
  • Drug: LX4211 Placebo
    Subjects will receive LX4211 placebo once daily for 7 days
  • Experimental: Treatment A
    Intervention: Drug: LX4211
  • Placebo Comparator: LX4211 Placebo
    Intervention: Drug: LX4211 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
Not Provided
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01555008
LX4211.1-107-DM, LX4211.107
No
Lexicon Pharmaceuticals
Lexicon Pharmaceuticals
Not Provided
Study Director: Ike Ogbaa, M.D. Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP