NIPH Clinical Trials Search

JRCT ID: jRCT2051210127

Registered date:27/11/2021

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)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedtype 2 diabetes
Date of first enrollment30/11/2021
Target sample size80
Countries of recruitmentCzech Republic,Japan,France,Japan,Germany,Japan,Hungary,,Japan,India,Japan,Italy,Japan,Malaysia,Japan,Poland,Japan,Slovenia,Japan,South Africa,Japan,Thailand,Japan,Turkey,Japan,United States,Japan
Study typeInterventional
Intervention(s)Participants will be randomised (1:1) to receive once weekly IcoSema or daily insulin glargine combined with 2-4 times daily injections of insulin aspart. -an up to 2 weeks screening period -a 52-week treatment period - a 5-week follow-up period


Primary OutcomeChange in HbA1c: From baseline week 0 (V2) to week 52 (V54)
Secondary Outcome-Change in body weight: From baseline week 0 (V2) to week 52 (V54) -Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3): From baseline week 0 (V2) to week 57 (V56) -Weekly insulin dose (total): From week 50 (V52) to week 52 (V54)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria-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.
Exclude criteria-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.

Related Information


Public contact
Name Hirotaka Miwa
Address 2-1-1, Marunouchi, Chiyodaku, Tokyo Tokyo Japan 100-0005
Telephone +81-362661000
Affiliation Novo Nordisk Pharma Ltd.
Scientific contact
Name Hirotaka Miwa
Address 2-1-1, Marunouchi, Chiyodaku, Tokyo Tokyo Japan 100-0005
Telephone +81-362661000
Affiliation Novo Nordisk Pharma Ltd.