Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: LX4211 Low Dose; Drug: LX4211 High Dose; Drug: Placebo

• Registration Number: NCT00962065
• Lead Sponsor: Lexicon Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Primary Completion: 2009-12
• Status Verified: 2011-02
• Results First Submitted: 2011-02-04
• Results First Submitted QC: 2011-02-04
• Last Update Submitted: 2011-02-04
• Results First Posted: 2011-03-03
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	LX4211 Low Dose	A low dose of LX4211; daily oral intake for 28 days
High Dose	LX4211 High Dose	A high dose of LX4211; daily oral intake for 28 days
Placebo	Placebo	Matching placebo dosing with daily oral intake for 28 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 San Antonio, Texas, United States