Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX4211 in Subjects With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: LX4211 Low Dose
* Drug: LX4211 High Dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose<br>A low dose of LX4211; daily oral intake for 28 days | Drug: LX4211 Low Dose<br>* A low dose of LX4211; daily oral intake for 28 days<br>|
| Experimental: High Dose<br>A high dose of LX4211; daily oral intake for 28 days | Drug: LX4211 High Dose<br>* A high dose of LX4211; daily oral intake for 28 days<br>|
| Placebo Comparator: Placebo<br>Matching placebo dosing with daily oral intake for 28 days | Drug: Placebo<br>* Matching placebo dosing with daily oral intake for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion | To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration. | Baseline to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at Day 29 in Fasting Plasma Glucose |  | Baseline to Day 29 | 
| Change From Baseline at Day 28 in Plasma HbA1c |  | Baseline to Day 28 | 
| Change From Baseline at Day 28 in Plasma Fructosamine Level |  | Baseline to Day 28 | 
| Change From Baseline at Day 28 in Mean Arterial Pressure |  | Baseline to Day 28 | 
| Change From Baseline at Day 28 in Triglycerides |  | Baseline to Day 28 |