Status:
COMPLETED
Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Adults aged 18 to 65 years of age
- 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
- History of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01188863
Start Date
September 1 2010
Last Update
March 30 2011
Active Locations (1)
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1
Lexicon Investigational Site
San Antonio, Texas, United States, 78209