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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376557
• Other study ID #: LX4211.1-202-DM
• Secondary ID: LX4211.202
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2011
• Last updated: October 29, 2014
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: October 2014
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 75 mg LX4211
Subjects will receive 75 mg LX4211 once daily
• 200 mg LX4211
Subjects will receive 200 mg LX4211 once daily.
• 400 mg LX4211
Subjects will receive 400 mg LX4211 once daily.
• 200 mg LX4211
Subjects will receive 200 mg LX4211 twice daily.
• Placebo
Subjects will receive placebo once daily.

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Anaheim	California
United States	Lexicon Investigational Site	Austin	Texas
United States	Lexicon Investigational Site	Baton Rouge	Louisiana
United States	Lexicon Investigational Site	Blue Ridge	Georgia
United States	Lexicon Investigational Site	Brockton	Massachusetts
United States	Lexicon Investigational Site	Canal Fulton	Ohio
United States	Lexicon Investigational Site	Carmichael	California
United States	Lexicon Investigational Site	Chattanooga	Tennessee
United States	Lexicon Investigational Site	Chattanooga	Tennessee
United States	Lexicon Investigational Site	Clinton	South Carolina
United States	Lexicon Investigational Site	Dallas	Texas
United States	Lexicon Investigational Site	Dayton	Ohio
United States	Lexicon Investigational Site	Denver	Colorado
United States	Lexicon Investigational Site	Denver	Colorado
United States	Lexicon Investigational Site	Edgewater	Florida
United States	Lexicon Investigational Site	Eugene	Oregon
United States	Lexicon Investigational Site	Grand Forks	North Dakota
United States	Lexicon Investigational Site	Great Neck	New York
United States	Lexicon Investigational Site	Greenbrae	California
United States	Lexicon Investigational Site	Greensboro	North Carolina
United States	Lexicon Investigational Site	Houston	Texas
United States	Lexicon Investigational Site	Houston	Texas
United States	Lexicon Investigational Site	Kansas City	Missouri
United States	Lexicon Investigational Site	Kettering	Ohio
United States	Lexicon Investigational Site	Killeen	Texas
United States	Lexicon Investigational Site	La Jolla	California
United States	Lexicon Investigational Site	Lafayette	Indiana
United States	Lexicon Investigational Site	Las Vegas	Nevada
United States	Lexicon Investigational Site	Las Vegas	Nevada
United States	Lexicon Investigational Site	Madisonville	Kentucky
United States	Lexicon Investigational Site	Miami	Florida
United States	Lexicon Investigational Site	Mt. Pleasant	South Carolina
United States	Lexicon Investigational Site	Newark	Delaware
United States	Lexicon Investigational Site	Northridge	California
United States	Lexicon Investigational Site	Ogden	Utah
United States	Lexicon Investigational Site	Olive Branch	Mississippi
United States	Lexicon Investigational Site	Omaha	Nebraska
United States	Lexicon Investigational Site	Orange	California
United States	Lexicon Investigational Site	Orlando	Florida
United States	Lexicon Investigational Site	Perrysburg	Ohio
United States	Lexicon Investigational Site	Pismo Beach	California
United States	Lexicon Investigational Site	Salt Lake City	Utah
United States	Lexicon Investigational Site	San Antonio	Texas
United States	Lexicon Investigational Site	San Antonio	Texas
United States	Lexicon Investigational Site	Savannah	Georgia
United States	Lexicon Investigational Site	Tarzana	California
United States	Lexicon Investigational Site	Tomball	Texas
United States	Lexicon Investigational Site	Traverse City	Michigan
United States	Lexicon Investigational Site	Tustin	California
United States	Lexicon Investigational Site	Uniontown	Pennsylvania
United States	Lexicon Investigational Site	Virginia Beach	Virginia
United States	Lexicon Investigational Site	Waltham	Massachusetts
United States	Lexicon Investigational Site	West Palm Beach	Florida
United States	Lexicon Investigational Site	West Seneca	New York
United States	Lexicon Investigational Site	Winston-Salem	North Carolina
United States	Lexicon Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c to Week 12		12 weeks	No
Secondary	Number of Participants Achieving a HbA1c Value of <7% at Week 12		12 weeks	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12		12 weeks	No
Secondary	Change From Baseline in Body Weight at Week 12		12 weeks	No
Secondary	Change From Baseline in Systolic Blood Pressure (SPB) at Week 12		12 weeks	No
Secondary	Change From Baseline in Triglycerides at Week 12		12 weeks	No