NCT01441232

Brief Summary

This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211 when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes Mellitus.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

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

September 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

September 23, 2011

Last Update Submit

January 26, 2012

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in gut hormones

    Days 1, 8, and 15

Secondary Outcomes (5)

  • Change from baseline in fasting plasma glucose

    Days 1, 8, and 15

  • Change from baseline in postprandial glucose

    Days 1, 8, and 15

  • Change from baseline in insulin

    Days 1, 8, and 15

  • Change from baseline in peptide YY

    Days 1, 8, and 15

  • Change from baseline in urinary glucose excretion

    Days 1, 8, and 15

Study Arms (3)

Treatment A

EXPERIMENTAL
Drug: LX4211

Treatment C

EXPERIMENTAL
Drug: LX4211Drug: Januvia®

Treatment B

ACTIVE COMPARATOR
Drug: Januvia®

Interventions

LX4211DRUG

400 mg of LX4211 administered as two 200 mg tablets

Treatment ATreatment C
Januvia®DRUG

100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet

Treatment BTreatment C

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
  • History of Type 2 Diabetes Mellitus for at least 3 months prior to Screening, with HgbA1c values of 6.5 to 10.5% and C-peptide ≥1.0 ng/mL
  • Body mass index (BMI) ≤45 kg/sq m
  • Willing and able to self-monitor blood glucose
  • Able to provide written informed consent

You may not qualify if:

  • History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
  • Current use of any blood glucose lowering agent other than metformin
  • History of renal disease or clinically significant abnormal kidney function tests at Screening or Day -2
  • Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or Day -2
  • History of myocardial infarction, severe/unstable angina, or coronary revascularization procedure within 6 months of Day -2
  • History of clinically significant cardiac arrhythmias within 1 year of Day -2
  • Congestive heart failure and/or New York Heart Association (NYHA) class III or IV symptoms of heart failure
  • Subjects with uncontrolled Stage 3 hypertension
  • History of 2 or more emergency room visits, doctor's visits, or hospitalizations due to hypoglycemia within 6 months of Day -2
  • History of alcohol or drug abuse within 12 months of Screening
  • History of bowel resection \> 20 cm, any malabsorptive disorder, severe gastroparesis, and GI procedure for the purpose of weight loss that would slow gastric emptying
  • History of HIV or hepatitis C
  • Major surgery within 3 months of Day -2 or any planned surgery during the study
  • History of any active infection within 2 weeks of Day -2
  • History of pancreatitis
  • +8 more criteria

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, Ding ZM, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Smith M, Ruff D, Sands A, Powell D. Effects of LX4211, a dual SGLT1/SGLT2 inhibitor, plus sitagliptin on postprandial active GLP-1 and glycemic control in type 2 diabetes. Clin Ther. 2013 Mar;35(3):273-285.e7. doi: 10.1016/j.clinthera.2013.01.010. Epub 2013 Feb 21.

    PMID: 23433601DERIVED

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-triolSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Ikenna Ogbaa, MD

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2011

First Posted

September 27, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)