Summary
A 26-week open-label study assessing the efficacy and safety of the insulin
glargine/lixisenatide fixed ratio combination in adults with Type 2 Diabetes
inadequately controlled on GLP-1 receptor agonist and metformin ± pioglitazone
Purpose of this Study:
You are being asked to participate in a study of the investigational drug, insulin glargine/lixisenatide.
The purpose of this study is to evaluate the effectiveness of the insulin glargine/lixisenatide fixed ratio combination self-injected once daily as compared to the glucagonlike peptide-1 (GLP-1) receptor agonists liraglutide (Victoza®) self-injected once daily, exenatide (Byetta®) self-injected twice daily, or exenatide extendedrelease (Bydureon®), albiglutide (Tanzeum®/Eperzan®) or dulaglutide (Trulicity®) self-injected
once weekly, taken in combination with metformin with or without pioglitazone (Actos®) in patients with T2DM.
The insulin glargine/lixisenatide fixed ratio combination is the combination of two products: insulin glargine and lixisenatide that have been shown to lower blood sugar.
Lixisenatide:
In humans, a substance called GLP-1 is produced in the small bowel and is releasedinto your body when eating. Once released, GLP-1 stimulates your pancreas to produce more insulin (a substance that decreases blood sugar) and prevents it from producing glucagon (a substance that increases blood sugar). Patients with type 2 diabetes mellitus often have a lower and slower release of GLP-1 compared to healthy persons, which can cause blood sugar levels to increase in an unfavorable way after meals. GLP-1 can also cause the stomach to take longer to empty after a meal. It is known that this effect might decrease blood sugar after a meal, reduce appetite and subsequently body weight, but it might also lead to feelings of fullness, nausea and vomiting.
Lixisenatide is a GLP-1 receptor agonist. It acts like a natural GLP-1 and is more stablefin a patient’s blood than the natural GLP-1. Lixisenatide is injected once a day subcutaneously (injection under the skin). A large clinical program (13 studies with a duration ranging from 12 to more than 76 weeks) has been conducted throughout 50 countries and approximately 1200 sites to assess the safety and efficacy of lixisenatide given once daily at a dose of 20 μg. More than 5900 adult patients with type 2 diabetes mellitus (more than 3800 of them receiving lixisenatide) have been enrolled. In the studies already completed and analyzed so far, the efficacy of lixisenatide on blood sugar control was confirmed and lixisenatide was safe and well tolerated. Based on this clinical program, lixisenatide has been approved in 2013 in the European Union, Japan, Mexico, Brazil, Columbia, Chile, Australia and other countries (under trade name Lyxumia®) to treat adult patients with Type 2 diabetes, and its registration file is being reviewed in several other countries, including
the US.
Insulin Glargine (Lantus®):
Insulin glargine is a long-acting human insulin analogue resulting in an extended duration of action to 24 hours. Lantus® is injected once a day subcutaneously (injection under the skin).
Lantus®, like other basal insulins, mainly acts on (although not exclusively) the fasting blood sugar level. Lantus® has been marketed and used since June 2000 in Europe and since May 2001 in the USA and other parts of the world.
Insulin Glargine/Lixisenatide Fixed Ratio Combination:
Combining insulin glargine (acting mainly on fasting blood sugar) and lixisenatide (acting mainly on blood sugar after meals), would address two important medical needs for patients with Type 2 diabetes: lowering increased blood sugar when fasting and after a meal. This study will evaluate the efficacy and safety of once daily injection of a defined dose of combined insulin glargine and lixisenatide. This fixed ratio combination has been previously tested in 3 studies each of approximately 6 months duration comparing the efficacy and safety of the fixed ratio combination versus insulin glargine (in all 3 studies) and vs. lixisenatide (in 1 of the studies) in over 2000 patients with type 2 diabetes. In all 3 studies, the fixed ratio combination improved blood sugar control and was well tolerated.
If you are assigned to this group: You will inject the combination with a pre-filled disposable SoloStar® pen-injector. There are 2 SoloStar® pens (Peach Pen and Olive Pen) with different insulin glargine/lixisenatide fixed ratios to allow insulin glargine titration over a range of 10 to 60 U/day while limiting the lixisenatide dose to a maximum of 20 μg/day (this is the dose tested in the previous studies and which is marketed in the countries where lixisenatide is approved). Your study doctor will determine which pen you will use, and you will be instructed how to use the pen by either your study doctor or a study nurse.
The dose of the combination is titrated according to your insulin need. Only the dose of insulin glargine appears in the pen dosing window. The dose of lixisenatide does not appear in the dose window even though lixisenatide is pre-mixed in the cartridge. The lixisenatide dose is increased or decreased along with insulin glargine dose changes and also depends on which pen (Peach or Olive) is used.
Apply for study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study you may also fill out the online application HERE.