A 24-week, multinational, multicentre, randomised, open label, parallel-group treat-to-target trial to compare efiicacy and safety of thrice daily versus twice daily NovoMixÂ®30 (Biphasic insulin aspart 30) in subjects with the type 2 diabetes inadequately controlled with basal insulin - BIAsp 4200

ovo Nordisk India Private Ltd0 个研究点目标入组 45 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or female, age >= 18 years at the time of signing informed consent 2. Type 2 diabetes subjects clinically diagnosed >= 12 months prior to the day of screening (Visit 1)
•3. Treated with basal insulin >= 90 days prior to the day of screening (Visit 1). The following basal insulin are allowed :
•â?? insulin analogue once daily (OD)
•â?? Neutral Protamine Hagedorn (NPH) OD or BID
•4. Treatment with metformin with or without one additional OAD for at least 90 days prior to the day of screening (Visit 1)
•o Metformin must be at a stable dose of at least 1500 mg daily or maximum tolerated dose for at least 60 days prior to screening (Visit 1)
•â?? One additional OAD:
•o Sulphonylurea
•o Î±-glucosidase inhibitors
•o Dipeptidyl-peptidase-4 inhibitors
•o Sodium glucose co-transporter 2 (SGLT2) inhibitors (if applicable)
•5. HbA1c 7.5%â??10.0% (both inclusive) by central laboratory analysis at screening (Visit 1)
•6. Able and willing to intake three main meals daily (breakfast, lunch and main evening meal)
•throughout the trial. Definition of main meal as judged by the investigator

•1. Previous insulin intensification regimen for more than 14 days: premixed insulin thrice daily,
•basal-bolus regimen or continuous subcutaneous insulin infusion (CSII). Treatment during
•hospitalisation or during gestational diabetes is allowed for periods longer than 14 days
•2. Anticipated initiation or change in concomitant medications for more than 14 consecutive
•days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat,
•thyroid hormones, systemic corticosteroids)
•3. Impaired liver function, defined as alanine aminotransferase (ALT) >= 2.5 times upper
•normal limit at screening (Visit 1)

发起方

ovo Nordisk India Private Ltd