Study of LX4211 in Subjects With Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Lexicon Pharmaceuticals
Information provided by:	Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00962065

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 II

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:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	36
Study Start Date:	August 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low Dose: Experimental 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
High Dose: Experimental 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: Placebo Comparator 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

Responsible Party:	Lexicon Pharmaceuticals, Inc. ( Joel P. Freiman, MD, MPH - Medical Director )
ClinicalTrials.gov Identifier:	NCT00962065 History of Changes
Other Study ID Numbers:	LX4211.1-201-DM, LX4211.201
Study First Received:	August 10, 2009
Last Updated:	January 20, 2010
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 August 31, 2010