Upstate Active Clinical Trials Seeking Participants
Study title
A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients with Type 2 Diabetes Mellitus. The ELEMENT 2 Study.
IRB number
245197
What is the purpose of the study?
To compare the safety and efficacy of LY2963016 to Lantus in patients with Type 2 Diabetes Mellitus and to test the hypothesis that LY2963016 given once daily is noninferior to Lantus given once daily.
Who is eligible?
Have Type 2 Diabetes for at least 6 months,
Are 18 years old or older,
Are currently taking 2 or more oral diabetes medications at stable doses for at least 3 months (with or without Lantus taken once a day, HbA1c currently between 7.0% - 11.0%
What is involved if I participate?
- How long is the study?
Approximately 7 months - Is transportation provided or reimbursed?
Yes - Is parking provided or reimbursed?
Yes - What tests and procedures are involved?
Procedures/Tests: Study related blood tests, ECGs, physical exams, vital signs done at study visits. Subject required to keep a blood glucose diary and do 4-point and 7-point blood glucose testing at various times during the study. Other: Subject must be willing and able to learn to inject study medication once a day. Background oral diabetes medications will be paid for by Pharmacy Card supplied by sponsor. Study medication, glucose monitor and testing supplies, and stipend provided to participants.
Who is the doctor administering the study?
Ruth Weinstock, MD, PhD
Where will the study take place?
Clinical Research Unit at Institute for Human Performance
Over what time period is the study scheduled to run?
June 2012 June 2013
Who can I contact for more information?
- Name: Sarah Doolittle, BS, CCRC
- Phone: (315) 464-9008
- Email: Doolitsj@upstate.edu
- Fax: (315) 464-9076
If you are interested in this trial, please contact the study coordinator or investigator noted above.
