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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of LX4211 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: 75 mg LX4211
* Drug: 200 mg LX4211
* Drug: 400 mg LX4211
* Drug: 200 mg LX4211
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: 75 mg LX4211<br>* Subjects will receive 75 mg LX4211 once daily<br>|
| Experimental: Treatment B<br> | Drug: 200 mg LX4211<br>* Subjects will receive 200 mg LX4211 once daily.<br>|
| Experimental: Treatment C<br> | Drug: 400 mg LX4211<br>* Subjects will receive 400 mg LX4211 once daily.<br>|
| Experimental: Treatment D<br> | Drug: 200 mg LX4211<br>* Subjects will receive 200 mg LX4211 twice daily.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subjects will receive placebo once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c to Week 12 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving a HbA1c Value of <7% at Week 12 |  | 12 weeks | 
| Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 |  | 12 weeks | 
| Change From Baseline in Body Weight at Week 12 |  | 12 weeks | 
| Change From Baseline in Systolic Blood Pressure (SPB) at Week 12 |  | 12 weeks | 
| Change From Baseline in Triglycerides at Week 12 |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus