DiabetesPhase 3NCT01467323
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
A Phase 3 study testing biphasic insulin aspart and biphasic human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 37 sites in 5 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes. 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 and biphasic human insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 37 sitesin 5 countries
- Study dates
- Apr 1998to Sep 1998
- 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
- Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
- Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
- Body mass index (BMI) below or equal to 35.0 kg/m^2
- HbA1c below or equal to 11.0%
Who cannot join
- Total daily insulin dose at least 1.4 IU/kg
- Treatment with oral hypoglycaemic agents within the month prior to inclusion
- Recurrent severe hypoglycaemia (as judged by the investigator)
- Active proliferative retinopathy
- Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
- History of pancreatitis
Trial locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
Germany16 sites
Novo Nordisk Investigational Site
Anklam, 17389
Novo Nordisk Investigational Site
Berlin, 10559
Novo Nordisk Investigational Site
Berlin, 14089
Novo Nordisk Investigational Site
Cottbus, 03048
Novo Nordisk Investigational Site
Erkner, 15537
Novo Nordisk Investigational Site
Hamburg, 20251
Novo Nordisk Investigational Site
Jena, 07743
Novo Nordisk Investigational Site
Leipzig, 04177
Novo Nordisk Investigational Site
München, 80804
Novo Nordisk Investigational Site
Neunkirchen, 66538
Novo Nordisk Investigational Site
Quakenbrück, 49610
Novo Nordisk Investigational Site
Rostock, 18057
Novo Nordisk Investigational Site
Saarlouis, 66740
Novo Nordisk Investigational Site
Schwedt, 16303
Novo Nordisk Investigational Site
Ulm, 89081
Novo Nordisk Investigational Site
Würzburg, 97080
United Kingdom15 sites
Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Bath, BA1 3NG
Novo Nordisk Investigational Site
Birmingham, B9 5SS
Novo Nordisk Investigational Site
Blackburn, BB3 3LR
Novo Nordisk Investigational Site
Bolton, BL1 4QS
Novo Nordisk Investigational Site
Bristol, BS2 8HW
Novo Nordisk Investigational Site
Kettering, NN16 8UZ
Novo Nordisk Investigational Site
Leicester, LE1 5WW
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
Newcastle, NE7 7DN
Novo Nordisk Investigational Site
Northampton, NN1 5BD
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Paisley, PA2 9PL
Novo Nordisk Investigational Site
Watford, WD18 0HB
Novo Nordisk Investigational Site
Whiston, L35 5DR
Ireland3 sites
Novo Nordisk Investigational Site
Cork
Novo Nordisk Investigational Site
Dublin, DUBLIN 8
Novo Nordisk Investigational Site
Dublin
Austria2 sites
Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Vienna, A 1080
About this study
Official title: An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.
- Being tested
- biphasic insulin aspart, biphasic human insulin
- 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 aspartDrug
Injected subcutaneously (under the skin) twice daily
biphasic human insulinDrug
Injected subcutaneously (under the skin) twice daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: biphasic insulin aspart |
| B | Active comparator | Not described Receives: Drug: biphasic human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycosylated haemoglobin A1c)
Secondary outcomes (3)
8-point blood glucose profiles
Incidence of hypoglycaemic episodes
Occurrence of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startApr 1998
- Primary completionSep 1998
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR,1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467323
- Sponsor's protocol ID
- ANA/DCD/038
- Status last verified
- Jan 2017
- First submitted
- 4 Nov 2011
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002 May;19(5):393-9. doi: 10.1046/j.1464-5491.2002.00733.x.
PubMed 12027927Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Rastam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care. 2002 May;25(5):876-82. doi: 10.2337/diacare.25.5.876.
PubMed 11978684
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
- An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT01467323
- Acronym / sponsor ID
- ANA/DCD/038
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Sep 1998 (actual)
- Study completion
- Sep 1998 (actual)
- First posted
- 8 Nov 2011 (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 evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: biphasic insulin aspart |
| B | Active comparator | Drug: biphasic human insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
- Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
- Body mass index (BMI) below or equal to 35.0 kg/m^2
- HbA1c below or equal to 11.0%
Key exclusion criteria (6 listed)
- Total daily insulin dose at least 1.4 IU/kg
- Treatment with oral hypoglycaemic agents within the month prior to inclusion
- Recurrent severe hypoglycaemia (as judged by the investigator)
- Active proliferative retinopathy
- Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
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 aspartInjected subcutaneously (under the skin) twice daily | Drug | A |
| biphasic human insulinInjected subcutaneously (under the skin) twice daily | Drug | B |
Primary outcome
HbA1c (glycosylated haemoglobin A1c)
3 secondary outcomes
8-point blood glucose profiles
Incidence of hypoglycaemic episodes
Occurrence of adverse events
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 12027927Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002 May;19(5):393-9. doi: 10.1046/j.1464-5491.2002.00733.x.
- Results publication: PubMed 11978684Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Rastam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care. 2002 May;25(5):876-82. doi: 10.2337/diacare.25.5.876.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biphasic insulin aspart and biphasic human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 37 sites in 5 countries.
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 4 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 37 sites in Germany, United Kingdom, Ireland, Austria, Switzerland. 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 NCT01467323, which also lists 2 linked publications.
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.