Effects of 5 or 10 gram of the protein hydrolysate InsuVital* on serum insulin and glucose levels in patients with type 2 diabetes mellitus and the influence of varying carbohydrate loads - Low dose InsuVital in type 2 Diabetes Mellitus

DSM Food Specialties0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•Use of insulin, sulfonylurea derivatives, meglitinides or other antidiabetic drugs except biguanides;
•BMI > 35 kg/m2;
•Females who are pregnant, have the intention to become pregnant within the study period, or who are lactating;
•A present and clinically significant history of ischemic heart disease (such as angina pectoris with an incidence of more than one attack/month), acute myocardial infarction within one year prior to the study or congestive heart failure (defined as NYHA class III or IV);
•Uncontrolled hypertension;
•Active, proliferative retinopathy
•Active or history of liver disease or impaired renal function (defined as a creatinin clearance calculated with the Cockcroft-Gault formula below 60 ml/min);
•Participation in a trial within 3 months prior to the start of the study or more then 4 times a year;
•Loss of 250 ml or more of blood within 3 months prior to screening;
•Any clinical condition, including use of co-medication or laboratory test results that in the opinion of the investigators may jeopardize the health status of the participants.

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