A 52-week study comparing the efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL combined with insulin aspart, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily basal insulin. (NN1535-4593:COMBINE 3) - COMBINE 3

Miwa Hirotaka0 个研究点目标入组 80 人开始时间: 2021年11月27日最近更新: 2024年4月1日

研究概览

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•Male or female and age above or equal to 18 years at the time of signing informed consent.
•-Diagnosed with type 2 diabetes mellitus >= 180 days before screening.
•-HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
•-Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day >= 90 days before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti-diabetic drugs with stable doses >=90 days before screening:
•-Metformin
•-Sulfonylureasa
•-Meglitinides (glinides)
•-DPP-4 inhibitors
•-Sodium-glucose co-transporter 2 inhibitors
•-Alpha-glucosidase-inhibitors
•-Thiazolidinediones
•-Marketed oral combination products only including the products listed above.
•-Body mass index (BMI) <=40.0 kg/m2.

•-Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
•- Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
•- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
•- Any episodes of diabetic ketoacidosis within 90 days before screening.
•- Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
•- Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
•- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
•- Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
•- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

发起方

Miwa Hirotaka