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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin degludec/insulin aspart

Drug: biphasic insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT02648217

NN5401-4243

U1111-1170-8304 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

263 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)