Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

October 29, 2014 updated by: Lexicon Pharmaceuticals

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of LX4211 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
299

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Lexicon Investigational Site
      • Carmichael, California, United States, 95608
        • Lexicon Investigational Site
      • Greenbrae, California, United States, 94904
        • Lexicon Investigational Site
      • La Jolla, California, United States, 92037
        • Lexicon Investigational Site
      • Northridge, California, United States, 91325
        • Lexicon Investigational Site
      • Orange, California, United States, 92868
        • Lexicon Investigational Site
      • Pismo Beach, California, United States, 93449
        • Lexicon Investigational Site
      • Tarzana, California, United States, 91356
        • Lexicon Investigational Site
      • Tustin, California, United States, 92780
        • Lexicon Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • Lexicon Investigational Site
      • Denver, Colorado, United States, 80220
        • Lexicon Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Lexicon Investigational Site
    • Florida
      • Edgewater, Florida, United States, 32132
        • Lexicon Investigational Site
      • Miami, Florida, United States, 33135
        • Lexicon Investigational Site
      • Orlando, Florida, United States, 32806
        • Lexicon Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Lexicon Investigational Site
      • Winter Park, Florida, United States, 32792
        • Lexicon Investigational Site
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • Lexicon Investigational Site
      • Savannah, Georgia, United States, 31406
        • Lexicon Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47904
        • Lexicon Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Lexicon Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Lexicon Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Lexicon Investigational Site
      • Waltham, Massachusetts, United States, 02453
        • Lexicon Investigational Site
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Lexicon Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Lexicon Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Lexicon Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Lexicon Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Lexicon Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Lexicon Investigational Site
    • New York
      • Great Neck, New York, United States, 11023
        • Lexicon Investigational Site
      • West Seneca, New York, United States, 14224
        • Lexicon Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27455
        • Lexicon Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Lexicon Investigational Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Lexicon Investigational Site
    • Ohio
      • Canal Fulton, Ohio, United States, 44614
        • Lexicon Investigational Site
      • Dayton, Ohio, United States, 45439
        • Lexicon Investigational Site
      • Kettering, Ohio, United States, 45429
        • Lexicon Investigational Site
      • Perrysburg, Ohio, United States, 43551
        • Lexicon Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Lexicon Investigational Site
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Lexicon Investigational Site
    • South Carolina
      • Clinton, South Carolina, United States, 29325
        • Lexicon Investigational Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Lexicon Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Lexicon Investigational Site
      • Chattanooga, Tennessee, United States, 37421
        • Lexicon Investigational Site
    • Texas
      • Austin, Texas, United States, 78728
        • Lexicon Investigational Site
      • Dallas, Texas, United States, 75230
        • Lexicon Investigational Site
      • Houston, Texas, United States, 77024
        • Lexicon Investigational Site
      • Houston, Texas, United States, 77098
        • Lexicon Investigational Site
      • Killeen, Texas, United States, 76543
        • Lexicon Investigational Site
      • San Antonio, Texas, United States, 78229
        • Lexicon Investigational Site
      • San Antonio, Texas, United States, 78258
        • Lexicon Investigational Site
      • Tomball, Texas, United States, 77375
        • Lexicon Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Lexicon Investigational Site
      • Salt Lake City, Utah, United States, 84109
        • Lexicon Investigational Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Lexicon Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects between the ages of 18 to 75 years, inclusive
  • Confirmed diagnosis of Type 2 diabetes mellitus
  • Meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dL
  • Stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks
  • Willing and able to provide written informed consent
  • Willing and able to maintain consistent dietary, physical activity, and sleeping patterns throughout the study

Exclusion Criteria:

  • History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
  • History of renal disease or clinically significant abnormal kidney function tests
  • Presence of active hepatic disease or clinically significant abnormal liver function tests
  • Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day 1
  • History of clinically significant cardiac arrhythmias within one year of study Day 1
  • Subjects with congestive heart failure
  • Subjects with uncontrolled Stage III hypertension
  • Triglycerides >1000 mg/dL at Screening
  • Known history of HIV or hepatitis C
  • History of illicit drug or alcohol abuse with one year of study Day 1
  • Have had 2 or more emergency room visits, doctor visits, or hospitalizations due to hypoglycemia within 6 months of study Day 1
  • Use of any other investigational drug within 30 days of study Day 1
  • Prior exposure to LX4211
  • Use of any medication or herbal supplement for the purpose of weight loss
  • Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study Day 1
  • Use of corticosteroids within 2 weeks prior to study Day 1
  • Major surgery within 6 months of study Day 1
  • Subjects with any history of severe gastroparesis
  • Inability or difficulty swallowing whole capsules or tablets
  • Women who are pregnant or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Subjects will receive placebo once daily.
EXPERIMENTAL: Treatment B
Drug: 200 mg LX4211
Subjects will receive 200 mg LX4211 once daily.
Drug: 200 mg LX4211
Subjects will receive 200 mg LX4211 twice daily.
EXPERIMENTAL: Treatment C
Drug: 400 mg LX4211
Subjects will receive 400 mg LX4211 once daily.
EXPERIMENTAL: Treatment A
Drug: 75 mg LX4211
Subjects will receive 75 mg LX4211 once daily
EXPERIMENTAL: Treatment D
Drug: 200 mg LX4211
Subjects will receive 200 mg LX4211 once daily.
Drug: 200 mg LX4211
Subjects will receive 200 mg LX4211 twice daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in HbA1c to Week 12
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants Achieving a HbA1c Value of <7% at Week 12
Time Frame: 12 weeks
12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12
Time Frame: 12 weeks
12 weeks
Change From Baseline in Body Weight at Week 12
Time Frame: 12 weeks
12 weeks
Change From Baseline in Systolic Blood Pressure (SPB) at Week 12
Time Frame: 12 weeks
12 weeks
Change From Baseline in Triglycerides at Week 12
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lexicon Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LX4211.1-202-DM
  • LX4211.202 (OTHER: Lexicon Pharmaceuticals, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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