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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02648217
• Date of registration: 05/01/2016
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: 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
• Scientific title: A Trial 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
• Date of first enrolment: January 2016
• Target sample size: 263
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02648217
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Algeria, India, Lebanon, Malaysia, South Africa, United Arab Emirates

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: biphasic insulin aspart

Drug: insulin degludec/insulin aspart

Primary Outcome(s)

Change in HbA1c (%) (glycosylated haemoglobin) [Time Frame: From week 0 to end of Ramadan (day 29 of Ramadan)]

Secondary Outcome(s)

Change in Fructosamine [Time Frame: From week 0 to end of Ramadan (day 29 of Ramadan)]

Number off subjects who achieve FPG below or equal to 7.2 mmol/L (ADA target) [Time Frame: End of Ramadan (day 29 of Ramadan)]

Change in fasting plasma glucose (FPG) [Time Frame: From week 0 to end of Ramadan (day 29 of Ramadan)]

Number of treatment emergent hypoglycaemic episodes both according to the Novo Nordisk definition for hypoglycaemic episodes (severe or BG hypoglycaemia) as well as according to the ADA definition1 confirmed symptomatic [Time Frame: From week 0 to 4 weeks post Ramadan]

Number of treatment emergent nocturnal (00:01-05:59 am) severe or BG confirmed symptomatic hypoglycaemic episodes [Time Frame: From week 0 to 4 weeks post Ramadan]

Number off subjects who achieve HbA1c below 7% (53 mmol/mol (American Diabetes Association (ADA) target ) [Time Frame: End of Ramadan (day 29 of Ramadan)]

Secondary ID(s)

U1111-1170-8304

NN5401-4243

Source(s) of Monetary Support

Please refer to primary and secondary sponsors