Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01188863
Last Updated: 2011-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Solid Oral Dose - 150 mg tablets
300 mg LX4211 (150 mg tablets)
Single oral dose of two 150 mg tablets LX4211
Solid Oral Dose - 50 mg tablets
300 mg LX4211 (50 mg tablets)
Single oral dose of six 50 mg tablets LX4211
Liquid Oral Dose
300 mg LX4211 (liquid)
Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)
Interventions
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300 mg LX4211 (150 mg tablets)
Single oral dose of two 150 mg tablets LX4211
300 mg LX4211 (50 mg tablets)
Single oral dose of six 50 mg tablets LX4211
300 mg LX4211 (liquid)
Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)
Eligibility Criteria
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Inclusion Criteria
* Males and females of non-childbearing potential
* Diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
* Fasting plasma glucose ≤240 mg/dL
* Body mass index \<42 kg/sq m
* HbA1c of 7-11%
* C-peptide of ≥1.0 ng/mL
* Ability to provide written informed consent
Exclusion Criteria
* Current use of any blood glucose-lowering agent other than metformin
* Exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
* History of HIV, Hepatitis B, or Hepatitis C
* Surgery within 6 months of screening
* Donation or loss of \>400 mL of blood or blood product within 8 weeks prior to start of study
* Use of proteins or antibodies within 12 weeks prior to screening. (Flu shots are allowed.)
* Exposure to any investigational agent or participation in an investigational trial within 30 days of the start of the study
* History of drug or alcohol abuse within 12 months prior to screening.
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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LX4211.102
Identifier Type: OTHER
Identifier Source: secondary_id
LX4211.1-102-DM
Identifier Type: -
Identifier Source: org_study_id