Upstate Active Clinical Trials Seeking Participants
Study title
A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus? Injected in the Morning or Evening in Patients with Type 1 Diabetes Mellitus with a 6-month Safety Extension Period
IRB number
359786
What is the purpose of the study?
The purpose of this study is to compare the effectiveness, safety and tolerability of a new more concentrated form of insulin glargine (named HOE901-U300) with that of the currently marketed insulin glargine U100, also known as Lantus? in patients with type 1 diabetes mellitus. In other words, both groups in this study will be taking active glargine but one group will have a more concentrated form.
Who is eligible?
The study is open to individuals with type 1 diabetes who are at least 18 years old and have been treated for at least one year with a long-acting (basal) insulin like Levemir, Lantus, or NPH plus a short-acting (bolus) insulin taken before meals such as Humalog, Novolog, or Apidra.
What is involved if I participate?
- How long is the study?
approximately 1 year - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
Yes - What tests and procedures are involved?
Participants will come to 10 study visits at the Clinical Research Unit, and participate in telephone visits in between clinic visits. Procedures during study visits include: physical exams, blood collection, urinalysis, ECG, questionnaire completion. Subjects will be asked to keep a diary of blood glucose readings throughout the study.
Who is the doctor administering the study?
Ruth Weinstock, MD, PhD
Where will the study take place?
Clinical Research Unit, IHP
Over what time period is the study scheduled to run?
December 2012 until enrollment is met
Who can I contact for more information?
- Name: Jane Bulger
- Phone: 315-464-9008
- Email: bulgerj@upstate.edu
- Fax: 315-464-9076
Other information:
Study insulin in pen form will be provided for the length of the study, along with a glucose meter and testing supplies
If you are interested in this trial, please contact the study coordinator or investigator noted above.
