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Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962065
First Posted: August 19, 2009
Last Update Posted: March 3, 2011
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.
Information provided by:
Lexicon Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:


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 ]
    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 ]
  • Change From Baseline at Day 28 in Plasma HbA1c [ Time Frame: Baseline to Day 28 ]
  • Change From Baseline at Day 28 in Plasma Fructosamine Level [ Time Frame: Baseline to Day 28 ]
  • Change From Baseline at Day 28 in Mean Arterial Pressure [ Time Frame: Baseline to Day 28 ]
  • Change From Baseline at Day 28 in Triglycerides [ Time Frame: Baseline to Day 28 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 10, 2009
First Posted: August 19, 2009
Results First Submitted: February 4, 2011
Results First Posted: March 3, 2011
Last Update Posted: March 3, 2011
Last Verified: February 2011

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