Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; biphasic insulin aspart
Intervention description: Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.; Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and
      safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily
      in subjects with type 2 diabetes mellitus before, during and after Ramadan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years at the time of signing informed consent.
             Algeria: Male or female, age at least 19 years at the time of signing informed consent

          -  Subjects diagnosed (clinically) with type 2 diabetes mellitus prior to day of
             screening (Visit 1)

          -  Treated with any pre-mix/self-mix or basal insulin regimen for at least 90 days prior
             to the day of screening (Visit 1)

          -  Subjects not on any OAD(s) (oral anti-diabetic drug) prior to trial participation OR
             subjects on fixed daily dose(s) of OAD(s) for at least 90 days prior to screening
             (Visit 1). The OAD(s) include any of the following anti-diabetic drug(s)/regimen:
             Biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented
             in the subject medical record) Insulin secretagogues (sulfonylureas (SU) and
             glinides), Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), a-glucosidase
             inhibitors, Sodium-glucose co-transporter 2- inhibitors (SGLT2 Inhibitors ) (above or
             equal to half of the maximum approved dose according to local label or maximum
             tolerated dose as documented in subject medical record)

          -  HbA1c 7.0%-10.0% (53-86 mmol/mol) (both inclusive, by central laboratory analysis)

          -  Intention to fast (daytime, i.e., between dawn and sunset) during Ramadan after
             receiving medical counselling regarding the risk of fasting

          -  Willing to give blood during Ramadan

        Exclusion Criteria:

          -  Any contraindication for successful and sustained fasting from a medical perspective
             at the discretion of the investigator (such as acute illness, severe hypoglycaemia
             within 90 days prior to screening (Visit 1), hypoglycaemia unawareness, ketoacidosis
             within 90 days prior to screening (Visit), hyperosmolar hyperglycaemic coma within 90
             days prior to screening (Visit 1), subjects performing intense physical labour)