Clinical trial NCT01376557: Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes mellitus
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in HbA1c to Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants Achieving a HbA1c Value of <7% at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12
timeFrame: 12 weeks
measure: Change From Baseline in Body Weight at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in Systolic Blood Pressure (SPB) at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in Triglycerides at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Lexicon Investigational Site
state: California
city: Carmichael
country: United States
facility: Lexicon Investigational Site
state: California
city: Greenbrae
country: United States
facility: Lexicon Investigational Site
state: California
city: La Jolla
country: United States
facility: Lexicon Investigational Site
state: California
city: Northridge
country: United States
facility: Lexicon Investigational Site
state: California
city: Orange
country: United States
facility: Lexicon Investigational Site
state: California
city: Pismo Beach
country: United States
facility: Lexicon Investigational Site
state: California
city: Tarzana
country: United States
facility: Lexicon Investigational Site
state: California
city: Tustin
country: United States
facility: Lexicon Investigational Site
state: California
city: Denver
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Denver
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Newark
country: United States
facility: Lexicon Investigational Site
state: Delaware
city: Edgewater
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Miami
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Orlando
country: United States
facility: Lexicon Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Blue Ridge
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Lafayette
country: United States
facility: Lexicon Investigational Site
state: Indiana
city: Madisonville
country: United States
facility: Lexicon Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Lexicon Investigational Site
state: Louisiana
city: Brockton
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: Waltham
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: Traverse City
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Olive Branch
country: United States
facility: Lexicon Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Lexicon Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Lexicon Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Lexicon Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Lexicon Investigational Site
state: Nevada
city: Great Neck
country: United States
facility: Lexicon Investigational Site
state: New York
city: West Seneca
country: United States
facility: Lexicon Investigational Site
state: New York
city: Greensboro
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Grand Forks
country: United States
facility: Lexicon Investigational Site
state: North Dakota
city: Canal Fulton
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Kettering
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Perrysburg
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Lexicon Investigational Site
state: Oregon
city: Uniontown
country: United States
facility: Lexicon Investigational Site
state: Pennsylvania
city: Clinton
country: United States
facility: Lexicon Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Lexicon Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: Lexicon Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Lexicon Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Killeen
country: United States
facility: Lexicon Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Tomball
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Ogden
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Virginia Beach
country: United States
facility: Lexicon Investigational Site
state: Virginia
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Ikenna Ogbaa, MD
role: STUDY_DIRECTOR
References:
citation: 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.