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

Novo Nordisk A/S1 site in 1 country263 target enrollmentJanuary 4, 2016

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec/insulin aspart biphasic insulin aspart

Drugsinsulin degludec/insulin aspart biphasic insulin aspart

Overview

Phase: Phase 3
Intervention: insulin degludec/insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 263
Locations: 1
Primary Endpoint: Change in HbA1c (%) (Glycosylated Haemoglobin)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 4, 2016

End Date

September 5, 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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)

Arms & Interventions

IDegAsp U100 BID

Intervention: insulin degludec/insulin aspart

BIAsp U100 BID

Intervention: biphasic insulin aspart

Outcomes

Primary Outcomes

Change in HbA1c (%) (Glycosylated Haemoglobin)

Time Frame: From week 0 to end of Ramadan (day 29 of Ramadan)

Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).

Secondary Outcomes

Change in Fructosamine(From week 0 to end of Ramadan (day 29 of Ramadan))
Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )(End of Ramadan (day 29 of Ramadan))
Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)(End of Ramadan (day 29 of Ramadan))
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(From week 0 to 4 weeks post 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(From week 0 to 4 weeks post Ramadan)
Change in Fasting Plasma Glucose (FPG)(From week 0 to end of Ramadan (day 29 of Ramadan))