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

NCT ID: NCT01376557

Last Updated: 2014-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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diabetes mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

Group Type EXPERIMENTAL

75 mg LX4211

Intervention Type DRUG

Subjects will receive 75 mg LX4211 once daily

Treatment B

Group Type EXPERIMENTAL

200 mg LX4211

Intervention Type DRUG

Subjects will receive 200 mg LX4211 once daily.

Treatment C

Group Type EXPERIMENTAL

400 mg LX4211

Intervention Type DRUG

Subjects will receive 400 mg LX4211 once daily.

Treatment D

Group Type EXPERIMENTAL

200 mg LX4211

Intervention Type DRUG

Subjects will receive 200 mg LX4211 twice daily.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive placebo once daily.

Interventions

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75 mg LX4211

Subjects will receive 75 mg LX4211 once daily

Intervention Type DRUG

200 mg LX4211

Subjects will receive 200 mg LX4211 once daily.

Intervention Type DRUG

400 mg LX4211

Subjects will receive 400 mg LX4211 once daily.

Intervention Type DRUG

200 mg LX4211

Subjects will receive 200 mg LX4211 twice daily.

Intervention Type DRUG

Placebo

Subjects will receive placebo once daily.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ikenna Ogbaa, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

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Lexicon Investigational Site

Anaheim, California, United States

Site Status

Lexicon Investigational Site

Carmichael, California, United States

Site Status

Lexicon Investigational Site

Greenbrae, California, United States

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Lexicon Investigational Site

La Jolla, California, United States

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Lexicon Investigational Site

Northridge, California, United States

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Lexicon Investigational Site

Orange, California, United States

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Lexicon Investigational Site

Pismo Beach, California, United States

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Lexicon Investigational Site

Tarzana, California, United States

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Lexicon Investigational Site

Tustin, California, United States

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Lexicon Investigational Site

Denver, Colorado, United States

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Denver, Colorado, United States

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Newark, Delaware, United States

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Lexicon Investigational Site

Edgewater, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Winter Park, Florida, United States

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Blue Ridge, Georgia, United States

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Savannah, Georgia, United States

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Lafayette, Indiana, United States

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Madisonville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Brockton, Massachusetts, United States

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Waltham, Massachusetts, United States

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Traverse City, Michigan, United States

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Olive Branch, Mississippi, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Lexicon Investigational Site

Great Neck, New York, United States

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Lexicon Investigational Site

West Seneca, New York, United States

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Lexicon Investigational Site

Greensboro, North Carolina, United States

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Lexicon Investigational Site

Winston-Salem, North Carolina, United States

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Lexicon Investigational Site

Grand Forks, North Dakota, United States

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Lexicon Investigational Site

Canal Fulton, Ohio, United States

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Lexicon Investigational Site

Dayton, Ohio, United States

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Lexicon Investigational Site

Kettering, Ohio, United States

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Perrysburg, Ohio, United States

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Eugene, Oregon, United States

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Lexicon Investigational Site

Uniontown, Pennsylvania, United States

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Lexicon Investigational Site

Clinton, South Carolina, United States

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Lexicon Investigational Site

Mt. Pleasant, South Carolina, United States

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Lexicon Investigational Site

Chattanooga, Tennessee, United States

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Lexicon Investigational Site

Chattanooga, Tennessee, United States

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Lexicon Investigational Site

Austin, Texas, United States

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Lexicon Investigational Site

Dallas, Texas, United States

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Lexicon Investigational Site

Houston, Texas, United States

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Lexicon Investigational Site

Houston, Texas, United States

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Lexicon Investigational Site

Killeen, Texas, United States

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Lexicon Investigational Site

San Antonio, Texas, United States

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Lexicon Investigational Site

San Antonio, Texas, United States

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Lexicon Investigational Site

Tomball, Texas, United States

Site Status

Lexicon Investigational Site

Ogden, Utah, United States

Site Status

Lexicon Investigational Site

Salt Lake City, Utah, United States

Site Status

Lexicon Investigational Site

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25216510 (View on PubMed)

Other Identifiers

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LX4211.202

Identifier Type: OTHER

Identifier Source: secondary_id

LX4211.1-202-DM

Identifier Type: -

Identifier Source: org_study_id