Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962065
• Other study ID #: LX4211.1-201-DM
• Secondary ID: LX4211.201
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2009
• Last updated: February 4, 2011
• Start date: August 2009

Study information

• Verified date: February 2011
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• LX4211 Low Dose
A low dose of LX4211; daily oral intake for 28 days
• LX4211 High Dose
A high dose of LX4211; daily oral intake for 28 days
• Placebo
Matching placebo dosing with daily oral intake for 28 days

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline at Day 29 in Fasting Plasma Glucose		Baseline to Day 29	No
Secondary	Change From Baseline at Day 28 in Plasma HbA1c		Baseline to Day 28	No
Secondary	Change From Baseline at Day 28 in Plasma Fructosamine Level		Baseline to Day 28	No
Secondary	Change From Baseline at Day 28 in Mean Arterial Pressure		Baseline to Day 28	No
Secondary	Change From Baseline at Day 28 in Triglycerides		Baseline to Day 28	No