Status:
COMPLETED
Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00962065
Start Date
August 1 2009
Last Update
March 3 2011
Active Locations (1)
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1
Lexicon Investigational Site
San Antonio, Texas, United States, 78209