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
  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:


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
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, see Learn About Clinical Studies.

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 July 20, 2014