Summary:
The treatment of Type 2 diabetes involves multiple approaches including following a special diet, an exercise routine, or taking medication, usually following a step-by-step treatment plan. It is important that blood glucose levels (the amount of sugar in your blood) remain approximately within the normal range to prevent or delay the complications caused by diabetes. - When diet and exercise are not sufficient to bring the blood glucose down to a desirable level, a drug taken orally (by mouth) such as metformin is usually first prescribed. However, over time many patients need to add a second or even third blood glucose lowering drug. When non-insulin blood-glucose lowering drugs become unable to control blood sugar levels, the addition of insulin may be recommended. Sotagliflozin (SAR439954) is an oral investigational drug being developed for the potential treatment of Type 2 diabetes. An “investigational drug” is a drug that has not been approved by government regulatory authorities, but can be used in research studies such as this one. Sotagliflozin works in the kidney to allow more sugar to be lost in the urine, and also reduces the amount of sugar that is absorbed in the intestine. In this way, it is thought to assist in lowering blood sugar in diabetes.
The primary purpose of this study is to determine whether sotagliflozin 400 mg or 200mg taken orally once daily lowers hemoglobin A1C (glycated hemoglobin, a blood test that measures how well your blood glucose is controlled over time) as well as glimepiride taken orally once daily in patients who have inadequate glycemic control with metformin. Glimepiride (Amaryl) is a drug that has been approved by the FDA to treat type 2 diabetes and belongs in the sulfonylurea family of drugs. You cannot participate in this study if you are allergic to sulfonylurea drugs or sulfonamide drugs (a family of antibacterial drugs). One of the institutions taking part in this study is listed on the first page of this document. The main study doctor for this institution is the doctor named as the Principal Investigator on the first page. The main study doctor will be helped by other study staff.
Qualified Participants Must:
• Be at least 18 years of age
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Must not have used a diabetic medication within the last 3 months other than Metfomin
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Must have been stable on Metformin dose for at least 3 months prior to screening
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Must be able to swallow pills whole
Qualified Participants May Receive:
- Compensation for time and travel expenses
- Physcials performed by a board certified physician
- Study related procedurues (blood work, EKG, etc.)
- Medication provided by study site