NCT02453685|CompletedPhase 4Results

A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients

A 32-week Randomised, Multinational, Treat-to-target, Open Label, Parallel Group Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp) 30 and Basal-bolus Therapy With Insulin Glargine and Insulin Aspart in Insulin naïve Type 2 Diabetic Patients Inadequately Controlled on Oral Anti-diabetic Therapy

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

BIASP-41572014-003708-62U1111-1158-7280

Study Type

interventional

Target

335

Locations

9 countries

Sites

Timeline

RegisteredMay 2015

StartedAug 2015

CompletionSep 2016

Brief Summary

This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

335

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Aug 2015

Geographic Reach

9 countries

41 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

1.1 years study duration

First Submitted

Initial submission to the registry

May 21, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed

3 months until next milestone

Study Start

First participant enrolled

August 31, 2015

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2016

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

February 8, 2019

Completed

Last Updated

February 8, 2019

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

May 21, 2015

Results QC Date

September 19, 2017

Last Update Submit

September 6, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin)
Change in HbA1c from baseline (week 0) to week 32.
Week 0, week 32

Secondary Outcomes (3)

HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes
After 32 weeks of treatment (yes/no)
Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions
Weeks 0-32
Total Daily Insulin Dose
Weeks 0-32

Study Arms (2)

BIAsp

EXPERIMENTAL

Drug: biphasic insulin aspart 30

IGlar + IAsp

ACTIVE COMPARATOR

Drug: insulin glargineDrug: insulin aspart

Interventions

biphasic insulin aspart 30DRUG

Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.

BIAsp

insulin glargineDRUG

Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.

IGlar + IAsp

insulin aspartDRUG

Injected s.c./subcutaneously once daily.

IGlar + IAsp

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, age at least 18 years at the time of signing informed consent
Type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening
Treatment with stable daily dose (for at least 90 days prior to screening) of: - Metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - Sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, DPP4i (dipeptidyl peptidase-4 inhibitor), SGLT2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation
Insulin-naïve. Short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes
HbA1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
Willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. The definition for 'main meal' will be according to the investigator's discretion

You may not qualify if:

Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents)
Impaired liver function, defined as ALT (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
Inadequately treated high blood pressure defined as Class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm Hg or diastolic equal to or above 100 mm Hg) in accordance with the National High Blood Pressure Education Program, 7th Joint National Committee1 and ESH/ESC 2013 Guidelines2
Within the past 180 days prior to randomisation, any of the following: Myocardial Infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack

Contact the study team to confirm eligibility.