NCT00962065

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 3, 2011

Completed
Last Updated

March 3, 2011

Status Verified

February 1, 2011

Enrollment Period

4 months

First QC Date

August 10, 2009

Results QC Date

February 4, 2011

Last Update Submit

February 4, 2011

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (3)

Low Dose

EXPERIMENTAL

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

Drug: LX4211 Low Dose

High Dose

EXPERIMENTAL

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

Drug: LX4211 High Dose

Placebo

PLACEBO COMPARATOR

Matching placebo dosing with daily oral intake for 28 days

Drug: Placebo

Interventions

LX4211 Low DoseDRUG

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

Low Dose
LX4211 High DoseDRUG

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

High Dose
PlaceboDRUG

Matching placebo dosing with daily oral intake for 28 days

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexicon Investigational Site

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

  • Zambrowicz B, Freiman J, Brown PM, Frazier KS, Turnage A, Bronner J, Ruff D, Shadoan M, Banks P, Mseeh F, Rawlins DB, Goodwin NC, Mabon R, Harrison BA, Wilson A, Sands A, Powell DR. LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2012 Aug;92(2):158-69. doi: 10.1038/clpt.2012.58. Epub 2012 Jul 4.

    PMID: 22739142DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Joel P. Freiman, MD, MPH
Organization
Lexicon Pharmaceuticals, Inc.
281-863-3000

Study Officials

  • Joel P. Freiman, MD, MPH

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 19, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Last Updated

March 3, 2011

Results First Posted

March 3, 2011

Record last verified: 2011-02

Locations

US(1)