Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.