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Clinical Trial 42563

New Port Richey, FL 34652


Study Summary:

Study 42563 Flyer
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We are seeking volunteers, age 18 and over, to participate in a research study comparing an investigational fast-acting insulin with NovoLog®.

You may qualify if you:

· Are currently taking insulin glargine, also known as Lantus®  

· Use NovoLog® for bolus insulin at least 3 times per day

Participants not meeting this criterion may also qualify, provided that they complete the run-in period during which NovoLog and Lantus will be administered so that, at the time of randomization, the participants have been on NovoLog and insulin glargine (100 U/mL) for at least 12 weeks (including any potential pre-screening administration).



Criteria:

Alternating use of SAR341402 and NovoLog, self-administered by subcutaneous injection at mealtime, starting with NovoLog for the first 4 weeks, then SAR341402 for 4 weeks, followed by NovoLog for 4 weeks and then SAR341402 for the last 4 weeks on top of Lantus as basal insulin.

-or- 

Continuous use of NovoLog, self-administrated by subcutaneous injection at mealtime, during the 16-week Treatment Period on top of Lantus as basal insulin.


Qualified Participants May Receive:

· Lantus® and investigational fast-acting insulin and/or NovoLog® (no placebo)

· Glucometer and testing supplies

· Payment for time and travel


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.