A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics
NCT ID: NCT01441232
Last Updated: 2012-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment A
LX4211
400 mg of LX4211 administered as two 200 mg tablets
Treatment C
LX4211
400 mg of LX4211 administered as two 200 mg tablets
Januvia®
100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet
Treatment B
Januvia®
100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet
Interventions
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LX4211
400 mg of LX4211 administered as two 200 mg tablets
Januvia®
100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet
Eligibility Criteria
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Inclusion Criteria
* History of Type 2 Diabetes Mellitus for at least 3 months prior to Screening, with HgbA1c values of 6.5 to 10.5% and C-peptide ≥1.0 ng/mL
* Body mass index (BMI) ≤45 kg/sq m
* Willing and able to self-monitor blood glucose
* Able to provide written informed consent
Exclusion Criteria
* Current use of any blood glucose lowering agent other than metformin
* History of renal disease or clinically significant abnormal kidney function tests at Screening or Day -2
* Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or Day -2
* History of myocardial infarction, severe/unstable angina, or coronary revascularization procedure within 6 months of Day -2
* History of clinically significant cardiac arrhythmias within 1 year of Day -2
* Congestive heart failure and/or New York Heart Association (NYHA) class III or IV symptoms of heart failure
* Subjects with uncontrolled Stage 3 hypertension
* History of 2 or more emergency room visits, doctor's visits, or hospitalizations due to hypoglycemia within 6 months of Day -2
* History of alcohol or drug abuse within 12 months of Screening
* History of bowel resection \> 20 cm, any malabsorptive disorder, severe gastroparesis, and GI procedure for the purpose of weight loss that would slow gastric emptying
* History of HIV or hepatitis C
* Major surgery within 3 months of Day -2 or any planned surgery during the study
* History of any active infection within 2 weeks of Day -2
* History of pancreatitis
* History of any malignancy within the last 5 years which would affect the diagnosis or assessment of LX4211 or sitagliptin
* History of any serious adverse reaction or hypersensitivity to LX4211 or sitagliptin
* Presence of any clinically significant physical, laboratory, or ECG findings or any concurrent condition at Screening that may interfere with the study in the opinion of the investigator
* Triglycerides \> 1000 mg/dL at Screening or Day -2
* Donation or loss of \>400 mL of blood or blood product within 8 weeks prior to Day -2
* Use of any tobacco product for the duration of study participation
* Use of corticosteroids within 2 weeks of Day 1
* Use of digoxin or warfarin within 2 weeks prior to Screening
18 Years
65 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Ikenna Ogbaa, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
San Antonio, Texas, United States
Countries
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References
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Zambrowicz B, Ding ZM, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Smith M, Ruff D, Sands A, Powell D. Effects of LX4211, a dual SGLT1/SGLT2 inhibitor, plus sitagliptin on postprandial active GLP-1 and glycemic control in type 2 diabetes. Clin Ther. 2013 Mar;35(3):273-285.e7. doi: 10.1016/j.clinthera.2013.01.010. Epub 2013 Feb 21.
Other Identifiers
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LX4211.105
Identifier Type: OTHER
Identifier Source: secondary_id
LX4211.1-105-DM
Identifier Type: -
Identifier Source: org_study_id