This trial is examining the effectiveness of alternating doses of SAR341402 and insulin aspart (Novolog) compared with a continuous dose of insulin aspart in patients with type 1 diabetes (T1D).
The main outcomes to be measured will be the similarity between the two drugs and side effects. This trial is recruiting across the United States.
The details
T1D is a chronic condition in which the pancreas produces no insulin. Insulin is a hormone needed to allow glucose to enter cells and produce energy. Insulinis a standard treatment for these patients and it comes in different forms. It can be given as one continuous dose along with a basal dose of insulin glargine (Lantus; background long-acting insulin).
This trial is examining an alternative treatment method involving alternating doses of two rapid-acting insulins. Insulin aspart and SAR341402 are both rapid acting. That means they work more quickly than other types of insulin. The main outcome to be measured is how the drug reacts in the body.
Who are they looking for?
184 participants are needed for this trial. Participants must have T1DM. They must have an HbA1c (blood test measuring blood glucose control over the past 3 months) below 10% and a body mass index of 35 kg/m² or lower. They must also be on a 3 times daily injection insulin regimen for 3 months and continuous insulin for 12 months.
Patients must not have had a surgery to remove the pancreas, an islet cell transplantation, severely low blood glucose (hypoglycemia) or severely high blood glucose that required a hospital stay in the past 3 months. Patients must not be on glucocorticoids or been on any immunosuppressive therapy and must not have had eye injections for diabetic eye disease in the past 3 months.
How will it work
There will be two groups. One group will self inject the alternating use of SAR341402 and insulin aspartat mealtimes. They will be started with insulin aspart for the first 4 weeks, then SAR341402 for 4 weeks, followed by insulin aspart for 4 weeks and then SAR341402 for the last 4 weeks. This group will also receive insulin glargine. The other group will receive the continuous dose of insulin aspart.
The main outcome to be measured is the way these drugs work in the body and side effects at 16 weeks follow up.
