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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: 200 mg LX4211; Drug: 75 mg LX4211; Drug: Placebo; Drug: 400 mg LX4211

Study type: Interventional

Funder types: Industry

Identifiers

NCT01376557

LX4211.1-202-DM

LX4211.202 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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299 participants in 5 patient groups, including a placebo group

Treatment A

Experimental group

Treatment:

Drug: 75 mg LX4211

Treatment B

Experimental group

Treatment:

Drug: 200 mg LX4211

Drug: 200 mg LX4211

Treatment C

Experimental group

Treatment:

Drug: 400 mg LX4211

Treatment D

Experimental group

Treatment:

Drug: 200 mg LX4211

Drug: 200 mg LX4211

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo