The separate and combined effects of long-term GIP and GLP-1 receptor activation in patients with type 2 diabetes - GIP-SEMA

Herlev Gentofte Hospital0 个研究点目标入组 60 人开始时间: 2021年3月12日最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•1.Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•2.Men and women 18 to 74 years of age (both inclusive) at the time of signing informed consent
•3.Diagnosed with type 2 diabetes for at least six months.
•- Treated only with diet and exercise or stable metformin treatment for at least 3 months and be willing to continue the metformin dose during the trial
•- Glycated haemoglobin (HbA1C) 58-91 mmol/mol for patients treated with diet and exercise
•- HbA1C 53-91 mmol/mol for patients treated with metformin
•4.Body mass index (BMI) >27 to 50 kg/m2
•5.Stable body weight (less than 3 kg self-reported change during the previous 90 days)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1.Type 1 diabetes
•2.Known or suspected hypersensitivity to trial product or related products.
•3.Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g. diabetes ketoacidosis) within 90 days prior to screening
•4.Previous participation in this trial. Participation is defined as signed informed consent.
•5.Participation in another clinical trial within 90 days before screening.
•6.Woman who are pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
•7.Any laboratory safety parameter at screening outside the laboratory ranges
•8.Any disorder which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.

发起方

Herlev Gentofte Hospital