NCT02648217|CompletedPhase 3Results

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

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/S ClinicalTrials.gov

Compare

2 other identifiers

NN5401-4243U1111-1170-8304

Study Type

interventional

Target

263

Locations

6 countries

Sites

Timeline

RegisteredJan 2016

StartedJan 2016

CompletionSep 2016

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

263

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jan 2016

Shorter than P25 for phase_3 diabetes

Geographic Reach

6 countries

32 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

January 4, 2016

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2016

Completed

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2016

Completed

2 years until next milestone

Results Posted

Study results publicly available

September 11, 2018

Completed

Last Updated

September 11, 2018

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

January 5, 2016

Results QC Date

September 4, 2017

Last Update Submit

December 20, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (%) (Glycosylated Haemoglobin)
Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
From week 0 to end of Ramadan (day 29 of Ramadan)

Secondary Outcomes (6)

Change in Fasting Plasma Glucose (FPG)
From week 0 to end of Ramadan (day 29 of Ramadan)
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 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
+1 more secondary outcomes

Study Arms (2)

IDegAsp U100 BID

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

BIAsp U100 BID

ACTIVE COMPARATOR

Drug: biphasic insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.

IDegAsp U100 BID

biphasic insulin aspartDRUG

Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.

BIAsp U100 BID

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.