Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT00962065
Last Updated: 2011-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low Dose
A low dose of LX4211; daily oral intake for 28 days
LX4211 Low Dose
A low dose of LX4211; daily oral intake for 28 days
High Dose
A high dose of LX4211; daily oral intake for 28 days
LX4211 High Dose
A high dose of LX4211; daily oral intake for 28 days
Placebo
Matching placebo dosing with daily oral intake for 28 days
Placebo
Matching placebo dosing with daily oral intake for 28 days
Interventions
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LX4211 Low Dose
A low dose of LX4211; daily oral intake for 28 days
LX4211 High Dose
A high dose of LX4211; daily oral intake for 28 days
Placebo
Matching placebo dosing with daily oral intake for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Lexicon Pharmaceuticals, Inc.
Principal Investigators
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Joel P. Freiman, MD, MPH
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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LX4211.201
Identifier Type: -
Identifier Source: secondary_id
LX4211.1-201-DM
Identifier Type: -
Identifier Source: org_study_id
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