Status:
COMPLETED
A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211 when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes Mellitus.
Eligibility Criteria
Inclusion
- Adults aged 18 to 65 years of age
- 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
- History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01441232
Start Date
October 1 2011
Last Update
January 31 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lexicon Investigational Site
San Antonio, Texas, United States, 78209