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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: LX4211 Low Dose
Drug: LX4211 High Dose
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: August 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose
A low dose of LX4211; daily oral intake for 28 days
 Drug: LX4211 Low Dose
A low dose of LX4211; daily oral intake for 28 days
Experimental: High Dose
A high dose of LX4211; daily oral intake for 28 days
 Drug: LX4211 High Dose
A high dose of LX4211; daily oral intake for 28 days
Placebo Comparator: Placebo
Matching placebo dosing with daily oral intake for 28 days
 Drug: Placebo
Matching placebo dosing with daily oral intake for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962065

Locations
United States, Texas
Lexicon Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Joel P. Freiman, MD, MPH Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided by Lexicon Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joel P. Freiman, MD, MPH - Medical Director, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00962065     History of Changes
Other Study ID Numbers: LX4211.1-201-DM, LX4211.201
Study First Received: August 10, 2009
Results First Received: February 4, 2011
Last Updated: February 4, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013