AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 2NCT01376557

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

A Phase 2 study testing 75 mg LX4211, 200 mg LX4211 and 400 mg LX4211 in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 56 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
75 mg LX4211, 200 mg LX4211 and 400 mg LX4211
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
299 participants
Where
56 sitesUnited States
Study dates
Jun 2011to May 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • Lexicon Investigational Site

    Anaheim, California, 92801

  • Lexicon Investigational Site

    Austin, Texas, 78728

  • Lexicon Investigational Site

    Baton Rouge, Louisiana, 70808

  • Lexicon Investigational Site

    Blue Ridge, Georgia, 30513

  • Lexicon Investigational Site

    Brockton, Massachusetts, 02301

  • Lexicon Investigational Site

    Canal Fulton, Ohio, 44614

  • Lexicon Investigational Site

    Carmichael, California, 95608

  • Lexicon Investigational Site

    Chattanooga, Tennessee, 37411

  • Lexicon Investigational Site

    Chattanooga, Tennessee, 37421

  • Lexicon Investigational Site

    Clinton, South Carolina, 29325

  • Lexicon Investigational Site

    Dallas, Texas, 75230

  • Lexicon Investigational Site

    Dayton, Ohio, 45439

  • Lexicon Investigational Site

    Denver, Colorado, 80209

  • Lexicon Investigational Site

    Denver, Colorado, 80220

  • Lexicon Investigational Site

    Edgewater, Florida, 32132

  • Lexicon Investigational Site

    Eugene, Oregon, 97404

  • Lexicon Investigational Site

    Grand Forks, North Dakota, 58201

  • Lexicon Investigational Site

    Great Neck, New York, 11023

  • Lexicon Investigational Site

    Greenbrae, California, 94904

  • Lexicon Investigational Site

    Greensboro, North Carolina, 27455

  • Lexicon Investigational Site

    Houston, Texas, 77024

  • Lexicon Investigational Site

    Houston, Texas, 77098

  • Lexicon Investigational Site

    Kansas City, Missouri, 64111

  • Lexicon Investigational Site

    Kettering, Ohio, 45429

  • Lexicon Investigational Site

    Killeen, Texas, 76543

  • Lexicon Investigational Site

    La Jolla, California, 92037

  • Lexicon Investigational Site

    Lafayette, Indiana, 47904

  • Lexicon Investigational Site

    Las Vegas, Nevada, 89101

  • Lexicon Investigational Site

    Las Vegas, Nevada, 89128

  • Lexicon Investigational Site

    Madisonville, Kentucky, 42431

  • Lexicon Investigational Site

    Miami, Florida, 33135

  • Lexicon Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • Lexicon Investigational Site

    Newark, Delaware, 19713

  • Lexicon Investigational Site

    Northridge, California, 91325

  • Lexicon Investigational Site

    Ogden, Utah, 84403

  • Lexicon Investigational Site

    Olive Branch, Mississippi, 38654

  • Lexicon Investigational Site

    Omaha, Nebraska, 68131

  • Lexicon Investigational Site

    Orange, California, 92868

  • Lexicon Investigational Site

    Orlando, Florida, 32806

  • Lexicon Investigational Site

    Perrysburg, Ohio, 43551

  • Lexicon Investigational Site

    Pismo Beach, California, 93449

  • Lexicon Investigational Site

    Salt Lake City, Utah, 84109

  • Lexicon Investigational Site

    San Antonio, Texas, 78229

  • Lexicon Investigational Site

    San Antonio, Texas, 78258

  • Lexicon Investigational Site

    Savannah, Georgia, 31406

  • Lexicon Investigational Site

    Tarzana, California, 91356

  • Lexicon Investigational Site

    Tomball, Texas, 77375

  • Lexicon Investigational Site

    Traverse City, Michigan, 49684

  • Lexicon Investigational Site

    Tustin, California, 92780

  • Lexicon Investigational Site

    Uniontown, Pennsylvania, 15401

  • Lexicon Investigational Site

    Virginia Beach, Virginia, 23454

  • Lexicon Investigational Site

    Waltham, Massachusetts, 02453

  • Lexicon Investigational Site

    West Palm Beach, Florida, 33401

  • Lexicon Investigational Site

    West Seneca, New York, 14224

  • Lexicon Investigational Site

    Winston-Salem, North Carolina, 27103

  • Lexicon Investigational Site

    Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: 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.

Being tested
75 mg LX4211, 200 mg LX4211, 400 mg LX4211, Placebo
Keywords
diabetes mellitus
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 75 mg LX4211Drug

    Subjects will receive 75 mg LX4211 once daily

  • 200 mg LX4211Drug

    Subjects will receive 200 mg LX4211 once daily.

  • 400 mg LX4211Drug

    Subjects will receive 400 mg LX4211 once daily.

  • 200 mg LX4211Drug

    Subjects will receive 200 mg LX4211 twice daily.

  • PlaceboDrug

    Subjects will receive placebo once daily.

Study groups in NCT01376557
Study groupRoleWhat they receive
Treatment AExperimentalNot described
Receives: Drug: 75 mg LX4211
Treatment BExperimentalNot described
Receives: Drug: 200 mg LX4211
Treatment CExperimentalNot described
Receives: Drug: 400 mg LX4211
Treatment DExperimentalNot described
Receives: Drug: 200 mg LX4211
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HbA1c to Week 12

    Measured: 12 weeks

Secondary outcomes (5)

  1. Number of Participants Achieving a HbA1c Value of <7% at Week 12

    Measured: 12 weeks

  2. Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12

    Measured: 12 weeks

  3. Change From Baseline in Body Weight at Week 12

    Measured: 12 weeks

  4. Change From Baseline in Systolic Blood Pressure (SPB) at Week 12

    Measured: 12 weeks

  5. Change From Baseline in Triglycerides at Week 12

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01376557
Sponsor's protocol ID
LX4211.1-202-DM
Other IDs
LX4211.202
Status last verified
Oct 2014
First submitted
16 Jun 2011
Last updated
31 Oct 2014
Data monitoring committee
No

Publications

  • Rosenstock J, Cefalu WT, Lapuerta P, Zambrowicz B, Ogbaa I, Banks P, Sands A. Greater dose-ranging effects on A1C levels than on glucosuria with LX4211, a dual inhibitor of SGLT1 and SGLT2, in patients with type 2 diabetes on metformin monotherapy. Diabetes Care. 2015 Mar;38(3):431-8. doi: 10.2337/dc14-0890. Epub 2014 Sep 11.

    PubMed 25216510

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 75 mg LX4211, 200 mg LX4211 and 400 mg LX4211 in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c to Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01376557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in