NCT02582242|CompletedPhase 4ResultsFDA Drug

Comparing Efficacy and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 (Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

A 24-week, Multinational, Multicentre, Randomised, Open Label, Parallel-group Treat-to-target Trial to Compare Efficacy and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 (Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

BIASP-4200U1111-1162-5508

Study Type

interventional

Target

437

Locations

7 countries

Sites

Timeline

RegisteredOct 2015

StartedOct 2015

CompletionApr 2017

Brief Summary

This trial is conducted in Asia. The aim of the trial is to compare efficacy and safety of thrice daily versus twice daily NovoMix® 30 (Biphasic insulin aspart 30) in subjects with type 2 diabetes inadequately controlled with basal insulin.

Trial Health

On Track

Trial Health Score

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

Enrollment

437

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Oct 2015

Geographic Reach

7 countries

50 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

1.5 years study duration

First Submitted

Initial submission to the registry

October 16, 2015

Completed

3 days until next milestone

Study Start

First participant enrolled

October 19, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2017

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

May 29, 2018

Completed

Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

October 16, 2015

Results QC Date

March 16, 2018

Last Update Submit

May 28, 2019

Conditions

Diabetes Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c was evaluated after 24 weeks of treatment. Missing data was imputed using the last observation carried forward (LOCF) method.
Week 0, Week 24

Secondary Outcomes (17)

Proportion of Subjects Achieving HbA1c Below 7.0%
Week 24
Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes.
Week 24
Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes (According to the Novo Nordisk Classification)
Week 24
Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Week 0-24
Number of Treatment Emergent Hypoglycaemic Episodes Classified According to Novo Nordisk Definition
Week 0-24
+12 more secondary outcomes

Study Arms (2)

BIAsp 30 TID

EXPERIMENTAL

Drug: biphasic insulin aspart 30

BIAsp 30 BID

ACTIVE COMPARATOR

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Administered subcutaneously (s.c., under the skin) thrice daily or twice daily. Subjects will continue with metformin all throughout the trial.

BIAsp 30 BIDBIAsp 30 TID

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. For Algeria only: age at least 19 years at the time of signing informed consent
Type 2 diabetes subjects clinically diagnosed for at least 12 months prior to the day of screening (Visit 1)
Treated with basal insulin for at least 90 days prior to the day of screening (Visit 1). The following basal insulin are allowed : insulin analogue once daily (OD) Neutral Protamine Hagedorn (NPH) OD or BID (twice daily)
Treatment with metformin with or without one additional OAD (oral antidiabetic drug) for at least 90 days prior to the day of screening (Visit 1) Metformin must be at a stable dose of at least 1500 mg daily or maximum tolerated dose for at least 60 days prior to screening (Visit 1) One additional OAD:Sulphonylurea/Glinides/ a-glucosidase inhibitors/Dipeptidyl-peptidase-4 inhibitors/Sodium glucose co-transporter 2 (SGLT2) inhibitors (if applicable)
HbA1c (glycosylated haemoglobin) 7.5%-10.0% (both inclusive) by central laboratory analysis at screening (Visit 1)
Able and willing to intake three main meals daily (breakfast, lunch and main evening meal) throughout the trial. Definition of main meal as judged by the investigator

You may not qualify if:

Previous insulin intensification regimen for more than 14 days: premixed insulin thrice daily, basal-bolus regimen or continuous subcutaneous insulin infusion (CSII). Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days
Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, systemic corticosteroids)
Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit at screening (Visit 1)

Contact the study team to confirm eligibility.