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

NCT01376557 | Completed Phase 2 Results

• 2 other identifiers: LX4211.1-202-DMLX4211.202
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 56

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c to Week 12

  12 weeks

Secondary Outcomes (5)

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

  12 weeks

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

  12 weeks

• Change From Baseline in Body Weight at Week 12

  12 weeks

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

  12 weeks

• Change From Baseline in Triglycerides at Week 12

  12 weeks

Study Arms (5)

Treatment A

EXPERIMENTAL

Drug: 75 mg LX4211

Treatment B

EXPERIMENTAL

Drug: 200 mg LX4211

Treatment C

EXPERIMENTAL

Drug: 400 mg LX4211

Treatment D

EXPERIMENTAL

Drug: 200 mg LX4211

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

75 mg LX4211 DRUG

Subjects will receive 75 mg LX4211 once daily

Treatment A

200 mg LX4211 DRUG

Subjects will receive 200 mg LX4211 once daily.

Treatment B

400 mg LX4211 DRUG

Subjects will receive 400 mg LX4211 once daily.

Treatment C

Placebo DRUG

Subjects will receive placebo once daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (56)

Lexicon Investigational Site

Anaheim, California, 92801, United States

Location

Lexicon Investigational Site

Carmichael, California, 95608, United States

Location

Lexicon Investigational Site

Greenbrae, California, 94904, United States

Location

Lexicon Investigational Site

La Jolla, California, 92037, United States

Location

Lexicon Investigational Site

Northridge, California, 91325, United States

Location

Lexicon Investigational Site

Orange, California, 92868, United States

Location

Lexicon Investigational Site

Pismo Beach, California, 93449, United States

Location

Lexicon Investigational Site

Tarzana, California, 91356, United States

Location

Lexicon Investigational Site

Tustin, California, 92780, United States

Location

Lexicon Investigational Site

Denver, Colorado, 80209, United States

Location

Lexicon Investigational Site

Denver, Colorado, 80220, United States

Location

Lexicon Investigational Site

Newark, Delaware, 19713, United States

Location

Lexicon Investigational Site

Edgewater, Florida, 32132, United States

Location

Lexicon Investigational Site

Miami, Florida, 33135, United States

Location

Lexicon Investigational Site

Orlando, Florida, 32806, United States

Location

Lexicon Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Lexicon Investigational Site

Winter Park, Florida, 32792, United States

Location

Lexicon Investigational Site

Blue Ridge, Georgia, 30513, United States

Location

Lexicon Investigational Site

Savannah, Georgia, 31406, United States

Location

Lexicon Investigational Site

Lafayette, Indiana, 47904, United States

Location

Lexicon Investigational Site

Madisonville, Kentucky, 42431, United States

Location

Lexicon Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

Lexicon Investigational Site

Brockton, Massachusetts, 02301, United States

Location

Lexicon Investigational Site

Waltham, Massachusetts, 02453, United States

Location

Lexicon Investigational Site

Traverse City, Michigan, 49684, United States

Location

Lexicon Investigational Site

Olive Branch, Mississippi, 38654, United States

Location

Lexicon Investigational Site

Kansas City, Missouri, 64111, United States

Location

Lexicon Investigational Site

Omaha, Nebraska, 68131, United States

Location

Lexicon Investigational Site

Las Vegas, Nevada, 89101, United States

Location

Lexicon Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Lexicon Investigational Site

Great Neck, New York, 11023, United States

Location

Lexicon Investigational Site

West Seneca, New York, 14224, United States

Location

Lexicon Investigational Site

Greensboro, North Carolina, 27455, United States

Location

Lexicon Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Lexicon Investigational Site

Grand Forks, North Dakota, 58201, United States

Location

Lexicon Investigational Site

Canal Fulton, Ohio, 44614, United States

Location

Lexicon Investigational Site

Dayton, Ohio, 45439, United States

Location

Lexicon Investigational Site

Kettering, Ohio, 45429, United States

Location

Lexicon Investigational Site

Perrysburg, Ohio, 43551, United States

Location

Lexicon Investigational Site

Eugene, Oregon, 97404, United States

Location

Lexicon Investigational Site

Uniontown, Pennsylvania, 15401, United States

Location

Lexicon Investigational Site

Clinton, South Carolina, 29325, United States

Location

Lexicon Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Lexicon Investigational Site

Chattanooga, Tennessee, 37411, United States

Location

Lexicon Investigational Site

Chattanooga, Tennessee, 37421, United States

Location

Lexicon Investigational Site

Austin, Texas, 78728, United States

Location

Lexicon Investigational Site

Dallas, Texas, 75230, United States

Location

Lexicon Investigational Site

Houston, Texas, 77024, United States

Location

Lexicon Investigational Site

Houston, Texas, 77098, United States

Location

Lexicon Investigational Site

Killeen, Texas, 76543, United States

Location

Lexicon Investigational Site

San Antonio, Texas, 78229, United States

Location

Lexicon Investigational Site

San Antonio, Texas, 78258, United States

Location

Lexicon Investigational Site

Tomball, Texas, 77375, United States

Location

Lexicon Investigational Site

Ogden, Utah, 84403, United States

Location

Lexicon Investigational Site

Salt Lake City, Utah, 84109, United States

Location

Lexicon Investigational Site

Virginia Beach, Virginia, 23454, United States

Location

Related Publications (1)

• 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.

  PMID: 25216510 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Paul Strumph
• Organization: Lexicon Pharmaceuticals, Inc.

pstrumph@lexpharma.com

(281) 863-3302

Study Officials

• Ikenna Ogbaa, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 31, 2014
• Results First Posted: October 31, 2014

Record last verified: 2014-10

Locations

US (56)