NCT01188863

Brief Summary

This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 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
15

participants targeted

Target at below P25 for phase_1 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

First Submitted

Initial submission to the registry

August 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

March 30, 2011

Status Verified

March 1, 2011

Enrollment Period

1 month

First QC Date

August 24, 2010

Last Update Submit

March 29, 2011

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma concentration

    Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).

  • Time at which maximum observed plasma concentration occurs

    Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).

  • Half-life of the drug in plasma

    Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).

Secondary Outcomes (5)

  • Plasma glucose

    Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.

  • Urinary glucose excretion

    Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up).

  • Insulin

    Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.

  • Peptide YY

    Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.

  • Glucagon-like Peptide 1

    Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.

Study Arms (3)

Solid Oral Dose - 150 mg tablets

EXPERIMENTAL
Drug: 300 mg LX4211 (150 mg tablets)

Solid Oral Dose - 50 mg tablets

EXPERIMENTAL
Drug: 300 mg LX4211 (50 mg tablets)

Liquid Oral Dose

EXPERIMENTAL
Drug: 300 mg LX4211 (liquid)

Interventions

300 mg LX4211 (150 mg tablets)DRUG

Single oral dose of two 150 mg tablets LX4211

Solid Oral Dose - 150 mg tablets
300 mg LX4211 (50 mg tablets)DRUG

Single oral dose of six 50 mg tablets LX4211

Solid Oral Dose - 50 mg tablets
300 mg LX4211 (liquid)DRUG

Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)

Liquid Oral Dose

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 to 65 years of age
  • Males and females of non-childbearing potential
  • Diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
  • Fasting plasma glucose ≤240 mg/dL
  • Body mass index \<42 kg/sq m
  • HbA1c of 7-11%
  • C-peptide of ≥1.0 ng/mL
  • Ability to provide written informed consent

You may not qualify if:

  • History of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia
  • Current use of any blood glucose-lowering agent other than metformin
  • Exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
  • History of HIV, Hepatitis B, or Hepatitis C
  • Surgery within 6 months of screening
  • Donation or loss of \>400 mL of blood or blood product within 8 weeks prior to start of study
  • Use of proteins or antibodies within 12 weeks prior to screening. (Flu shots are allowed.)
  • Exposure to any investigational agent or participation in an investigational trial within 30 days of the start of the study
  • History of drug or alcohol abuse within 12 months prior to screening.

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-triolFluid Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Joel P. Freiman, MD, MPH

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 26, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2010

Last Updated

March 30, 2011

Record last verified: 2011-03

Locations

US(1)