Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00962065
First received: August 10, 2009
Last updated: February 4, 2011
Last verified: February 2011

August 10, 2009
February 4, 2011
August 2009
December 2009   (final data collection date for primary outcome measure)
Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.
Safety and tolerability (physical examinations, monitoring of adverse events, clinical laboratory tests, vital signs measurements, and ECGs) [ Time Frame: Serially over the 28-day treatment period and 7-day post-dose followup ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00962065 on ClinicalTrials.gov Archive Site
  • Change From Baseline at Day 29 in Fasting Plasma Glucose [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: No ]
  • Change From Baseline at Day 28 in Plasma HbA1c [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline at Day 28 in Plasma Fructosamine Level [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline at Day 28 in Mean Arterial Pressure [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline at Day 28 in Triglycerides [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
Efficacy (urinary glucose excretion, oral glucose tolerance testing, plasma glucose and fructosamine levels) [ Time Frame: Serially over the 28-day treatment period and 7-day post-dose followup ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX4211 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: LX4211 Low Dose
    A low dose of LX4211; daily oral intake for 28 days
  • Drug: LX4211 High Dose
    A high dose of LX4211; daily oral intake for 28 days
  • Drug: Placebo
    Matching placebo dosing with daily oral intake for 28 days
  • Experimental: Low Dose
    A low dose of LX4211; daily oral intake for 28 days
    Intervention: Drug: LX4211 Low Dose
  • Experimental: High Dose
    A high dose of LX4211; daily oral intake for 28 days
    Intervention: Drug: LX4211 High Dose
  • Placebo Comparator: Placebo
    Matching placebo dosing with daily oral intake for 28 days
    Intervention: Drug: Placebo
Zambrowicz B, Freiman J, Brown PM, Frazier KS, Turnage A, Bronner J, Ruff D, Shadoan M, Banks P, Mseeh F, Rawlins DB, Goodwin NC, Mabon R, Harrison BA, Wilson A, Sands A, Powell DR. LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2012 Aug;92(2):158-69. doi: 10.1038/clpt.2012.58. Epub 2012 Jul 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females (non-childbearing potential), aged 18-65 years
  • Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening
  • Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout
  • Body mass index < 42 kg/m^2
  • HbA1c value of 7 to 11%
  • C-peptide ≥ 1.0 ng/mL
  • Ability to provide written informed consent

Exclusion Criteria:

  • History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
  • Use of any blood glucose lowering agent other than metformin
  • Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
  • Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator
  • Positive test result for glutamic acid decarboxylase (GAD) antibody
  • Surgery within 6 months of screening
  • Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1
  • Hypersensitivity to an SGLT2 inhibitor
  • History of drug or alcohol abuse within the last 12 months
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00962065
LX4211.1-201-DM, LX4211.201
No
Joel P. Freiman, MD, MPH - Medical Director, Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
Not Provided
Study Director: Joel P. Freiman, MD, MPH Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
February 2011

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