Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

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

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.

• Phase: Phase 2
• 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:

• 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 Criteria:

• 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