A clinical trial comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus - DUAL? IX

ovo Nordisk A/S0 个研究点目标入组 416 人2016年2月8日

概览

暂无简介。

注册库

who.int

开始日期

2016年2月8日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•1\. Male or female, age higher or equal to 18 years at the time of signing informed consent
•2\. Subjects diagnosed (clinically) with type 2 diabetes mellitus
•3\. HbA1c 7\.0\-11\.0% \[53\-97 mmol/mol] (both inclusive) by central laboratory analysis
•4\. Body mass index (BMI) higher or equal to 20 kg/m^2 and less than 40 kg/m^2
•5\. Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes
•6\. A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin
•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 376

•1\. Receipt of any investigational medicinal product within 90 days prior to screening
•2\. Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening
•3\. Use of glucagon\-like peptide\-1 (GLP\-1\) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening
•4\. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening
•5\. Subjects presently classified as being in NYHA Class III or IV
•6\. Renal impairment estimated Glomerular Filtration Rate less than 60 mL/min/1\.73 m^2 as per CKD\-EPI (Chronic Kidney Disease Epidemiology Collaboration)
•7\. Impaired liver function, defined as ALT higher or equal to 2\.5 times upper normal limit at screening
•8\. Known or suspected hypersensitivity to trial product(s) or related products