Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: LX4211 Low Dose; Drug: LX4211 High Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962065

LX4211.201

LX4211.1-201-DM

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups, including a placebo group

Low Dose

Experimental group

Description:

A low dose of LX4211; daily oral intake for 28 days

Treatment:

Drug: LX4211 Low Dose

High Dose

Experimental group

Description:

A high dose of LX4211; daily oral intake for 28 days

Treatment:

Drug: LX4211 High Dose

Placebo

Placebo Comparator group

Description:

Matching placebo dosing with daily oral intake for 28 days

Treatment:

Drug: Placebo