DiabetesPhase 3NCT01520818

Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

A Phase 3 study testing biphasic insulin aspart 50, biphasic insulin aspart 70 and biphasic human insulin 30 in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 77 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What is being tested?: biphasic insulin aspart 50, biphasic insulin aspart 70 and biphasic human insulin 30
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 666 participants
Where: 77 sitesin 5 countries
Study dates: Mar 2000to Apr 2001
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 1 or Type 2 diabetes
Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
Body mass index (BMI) maximum 40.0 kg/m^2

Who cannot join

History of drug or alcohol dependence
Impaired hepatic function
Impaired renal function
Cardiac disease
Proliferative retinopathy
Total daily insulin dose at least 1.80 IU/kg

Trial locations and contacts

77 sites in 5 countries.

Country

City, postcode or hospital

77 sites in 5 countries

United Kingdom29 sites

Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Ayrsh, KA2 0BE
Novo Nordisk Investigational Site
Bath, BA1 3NG
Novo Nordisk Investigational Site
Birmingham, B9 5SS
Novo Nordisk Investigational Site
Brighton, BN2 5BE
Novo Nordisk Investigational Site
Coventry, CV1 4FH
Novo Nordisk Investigational Site
Dundee, DD1 9SY
Novo Nordisk Investigational Site
Edgware, HA8 0AD
Novo Nordisk Investigational Site
Edinburgh, EH4 2XU
Novo Nordisk Investigational Site
Exeter, EX2 5AX
Novo Nordisk Investigational Site
Glasgow, G51 4TF
Novo Nordisk Investigational Site
Haywards Heath, RH16 4EX
Novo Nordisk Investigational Site
Ipswich, IP4 5PD
Novo Nordisk Investigational Site
Leeds, LS9 7TF
Novo Nordisk Investigational Site
Leicester, LE1 5WW
Novo Nordisk Investigational Site
London, E11 1NR
Novo Nordisk Investigational Site
London, N19 3UA
Novo Nordisk Investigational Site
Manchester, M13 0JE
Novo Nordisk Investigational Site
Manchester, M8 5RB
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Paisley, PA2 9PL
Novo Nordisk Investigational Site
Poole, BH15 2JB
Novo Nordisk Investigational Site
Rugby, CV22 5PX
Novo Nordisk Investigational Site
Scunthorpe, DN15 7BH
Novo Nordisk Investigational Site
Southampton, SO14 OYG
Novo Nordisk Investigational Site
Sunderland, SR4 7TP
Novo Nordisk Investigational Site
Swansea, SA6 6NL
Novo Nordisk Investigational Site
Watford, WD18 0HB
Novo Nordisk Investigational Site
Whiston, L35 5DR

Other trials in United Kingdom

France27 sites

Novo Nordisk Investigational Site
Amiens
Novo Nordisk Investigational Site
Avignon, 84902
Novo Nordisk Investigational Site
Bagnols-sur-Cèze, 30200
Novo Nordisk Investigational Site
Bordeaux, 33076
Novo Nordisk Investigational Site
Caen, 14033
Novo Nordisk Investigational Site
Colmar, 68024
Novo Nordisk Investigational Site
Dijon, 21079
Novo Nordisk Investigational Site
Dommartin-lès-Toul, 54201
Novo Nordisk Investigational Site
Grenoble, 38043
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Lorient, 56322
Novo Nordisk Investigational Site
Lyon, 69437
Novo Nordisk Investigational Site
Mâcon, 71000
Novo Nordisk Investigational Site
Marseille, 13009
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Nîmes, 30006
Novo Nordisk Investigational Site
Orléans
Novo Nordisk Investigational Site
Paris, 75007
Novo Nordisk Investigational Site
Paris, 75014
Novo Nordisk Investigational Site
Reims, 51056
Novo Nordisk Investigational Site
Roubaix, 59056
Novo Nordisk Investigational Site
Saint-Etienne
Novo Nordisk Investigational Site
Strasbourg, 67091
Novo Nordisk Investigational Site
Toulouse, 31054

Other trials in France

Netherlands11 sites

Novo Nordisk Investigational Site
's-Hertogenbosch, 5223 GV
Novo Nordisk Investigational Site
Alkmaar, 1815 JD
Novo Nordisk Investigational Site
Amersfoort, 3816 CP
Novo Nordisk Investigational Site
Arnhem
Novo Nordisk Investigational Site
Beverwijk
Novo Nordisk Investigational Site
Delft, 2625 AD
Novo Nordisk Investigational Site
Einhoven
Novo Nordisk Investigational Site
Hengelo, 7555 DL
Novo Nordisk Investigational Site
Rotterdam, 3011 TD
Novo Nordisk Investigational Site
Rotterdam, 3021 HC
Novo Nordisk Investigational Site
The Hague, 2597 AX

Other trials in Netherlands

Belgium7 sites

Novo Nordisk Investigational Site
Aalst, 9300
Novo Nordisk Investigational Site
Brussels, 1020
Novo Nordisk Investigational Site
Brussels, 1090
Novo Nordisk Investigational Site
Edegem, 2650
Novo Nordisk Investigational Site
Genk, 3600
Novo Nordisk Investigational Site
Jumet, 6040
Novo Nordisk Investigational Site
Liège, 4000

Other trials in Belgium

Ireland3 sites

Novo Nordisk Investigational Site
Dublin, DUBLIN 15
Novo Nordisk Investigational Site
Dublin, DUBLIN 7
Novo Nordisk Investigational Site
Dublin

Other trials in Ireland

About this study

Official title: A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

Conditions: Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart 50, biphasic insulin aspart 70, biphasic human insulin 30
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

biphasic insulin aspart 50Drug
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m^2 will receive BIAsp 50
biphasic insulin aspart 70Drug
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m^2 will receive BIAsp 70
biphasic human insulin 30Drug
Administered subcutaneously (s.c., under the skin), twice a day

Study groups in NCT01520818
Study group	Role	What they receive
BIAsp 50 or 70	Experimental	Not described Receives: Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70
BHI 30	Active comparator	Not described Receives: Drug: biphasic human insulin 30

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c (glycosylated haemoglobin A1c)

Secondary outcomes (5)

Blood glucose profiles
Adverse events
Hypoglycaemic episodes
Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)
Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2000Apr 2001

First posted30 Jan 2012 (estimated)
Study startMar 2000
Primary completionApr 2001
Study completionApr 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 666 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01520818
Sponsor's protocol ID: BIASP-1075
Status last verified: Jan 2017
First submitted: 25 Jan 2012
Last updated: 4 Jan 2017
Results posted: No
Data monitoring committee: No

Publications

Clements MR, Tits J, Kinsley BT, Rastam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.
PubMed 18269638

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes
ClinicalTrials.gov ID: NCT01520818
Acronym / sponsor ID: BIASP-1075
Conditions: Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 666 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Mar 2000
Primary completion: Apr 2001 (actual)
Study completion: Apr 2001 (actual)
First posted: 30 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BIAsp 50 or 70	Experimental	Drug: biphasic insulin aspart 50, Drug: biphasic insulin aspart 70
BHI 30	Active comparator	Drug: biphasic human insulin 30

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Type 1 or Type 2 diabetes
Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
Body mass index (BMI) maximum 40.0 kg/m^2

Key exclusion criteria (6 listed)

History of drug or alcohol dependence
Impaired hepatic function
Impaired renal function
Cardiac disease
Proliferative retinopathy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
biphasic insulin aspart 50Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m^2 will receive BIAsp 50	Drug	BIAsp 50 or 70
biphasic insulin aspart 70Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m^2 will receive BIAsp 70	Drug	BIAsp 50 or 70
biphasic human insulin 30Administered subcutaneously (s.c., under the skin), twice a day	Drug	BHI 30

Primary outcome

HbA1c (glycosylated haemoglobin A1c)

5 secondary outcomes

Blood glucose profiles
Adverse events
Hypoglycaemic episodes
Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)
Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
Results publication: PubMed 18269638Clements MR, Tits J, Kinsley BT, Rastam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR,1452) study director

Novo Nordisk A/S

77 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United Kingdom, France, Netherlands, Belgium, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (glycosylated haemoglobin A1c). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01520818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.