Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.

• 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; Metformin

Criteria

Inclusion Criteria:

• Adult subjects between the ages of 18 to 75 years, inclusive

• Confirmed diagnosis of Type 2 diabetes mellitus

• Meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dL

• Stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks

• Willing and able to provide written informed consent

• Willing and able to maintain consistent dietary, physical activity, and sleeping patterns throughout the study

Exclusion Criteria:

• History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes

• History of renal disease or clinically significant abnormal kidney function tests

• Presence of active hepatic disease or clinically significant abnormal liver function tests

• Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day 1

• History of clinically significant cardiac arrhythmias within one year of study Day 1

• Subjects with congestive heart failure

• Subjects with uncontrolled Stage III hypertension

• Triglycerides >1000 mg/dL at Screening

• Known history of HIV or hepatitis C

• History of illicit drug or alcohol abuse with one year of study Day 1

• Have had 2 or more emergency room visits, doctor visits, or hospitalizations due to hypoglycemia within 6 months of study Day 1

• Use of any other investigational drug within 30 days of study Day 1

• Prior exposure to LX4211

• Use of any medication or herbal supplement for the purpose of weight loss

• Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study Day 1

• Use of corticosteroids within 2 weeks prior to study Day 1

• Major surgery within 6 months of study Day 1

• Subjects with any history of severe gastroparesis

• Inability or difficulty swallowing whole capsules or tablets

• Women who are pregnant or breast feeding