Skip to main content
OpenTrials
Completed

NCT Number: NCT00962065

Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lexicon Investigational Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LX4211 Low Dose

Drug

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

LX4211 High Dose

Drug

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

Placebo

Drug

Matching placebo dosing with daily oral intake for 28 days

Primary outcomes

  1. Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion

    Time frame: 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 outcomes

  1. Change From Baseline at Day 29 in Fasting Plasma Glucose

    Time frame: Baseline to Day 29

  2. Change From Baseline at Day 28 in Plasma HbA1c

    Time frame: Baseline to Day 28

  3. Change From Baseline at Day 28 in Plasma Fructosamine Level

    Time frame: Baseline to Day 28

  4. Change From Baseline at Day 28 in Mean Arterial Pressure

    Time frame: Baseline to Day 28

  5. Change From Baseline at Day 28 in Triglycerides

    Time frame: Baseline to Day 28

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
First posted
Aug 19, 2009
Registry last updated
Mar 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.