DiabetesPhase 3NCT01520753
Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes
A Phase 3 study testing biphasic insulin aspart 70 and biphasic insulin aspart 50 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with 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 2
- What is being tested?
- biphasic insulin aspart 70 and biphasic insulin aspart 50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 1999to Jun 1999
- 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 2 diabetes
- Duration of diabetes for longer than 12 months
- Body mass index (BMI) below 35.0 kg/m^2
- HbA1c below 11.0 %
- Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)
Who cannot join
- Current treatment with agents affecting glucose metabolism
- History of drug or alcohol dependence
- Impaired hepatic function
- Impaired renal function
- Cardiac disease
- Proliferative retinopathy
- Recurrent severe hypoglycaemia or advanced neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 70, biphasic insulin aspart 50
- Medical subject headings
- Diabetes Mellitus, 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 70Drug
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
biphasic insulin aspart 70Drug
Administered subcutaneously (s.c., under the skin) at breakfast and lunch
biphasic insulin aspart 50Drug
Administered subcutaneously (s.c., under the skin) at dinner
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 70 | Experimental | Not described Receives: Drug: biphasic insulin aspart 70 |
| BIAsp 70 + BIAsp 50 | Experimental | Not described Receives: Drug: biphasic insulin aspart 70; Drug: biphasic insulin aspart 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting serum glucose
Secondary outcomes (4)
24-hour serum glucose profiles
24-hour insulin profiles
Incidence of hypoglycaemic episodes
Incidence 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 posted30 Jan 2012 (estimated)
- Study startMar 1999
- Primary completionJun 1999
- Study completionJun 1999
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 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
- NCT01520753
- Sponsor's protocol ID
- BIASP-1074
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2012
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ejskjaer N, Rasmussen M, Kamp N, Lindholm A, Christiansen JS. Comparison of thrice daily 'high' vs. 'medium' premixed insulin aspart with respect to evening and overnight glycaemic control in patients with type 2 diabetes. Diabetes Obes Metab. 2003 Nov;5(6):438-45. doi: 10.1046/j.1463-1326.2003.00299.x.
PubMed 14617230
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 Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01520753
- Acronym / sponsor ID
- BIASP-1074
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- Primary completion
- Jun 1999 (actual)
- Study completion
- Jun 1999 (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 two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIAsp 70 | Experimental | Drug: biphasic insulin aspart 70 |
| BIAsp 70 + BIAsp 50 | Experimental | Drug: biphasic insulin aspart 70, Drug: biphasic insulin aspart 50 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes
- Duration of diabetes for longer than 12 months
- Body mass index (BMI) below 35.0 kg/m^2
- HbA1c below 11.0 %
- Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)
Key exclusion criteria (7 listed)
- Current treatment with agents affecting glucose metabolism
- History of drug or alcohol dependence
- Impaired hepatic function
- Impaired renal function
- Cardiac disease
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 70Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner | Drug | BIAsp 70 |
| biphasic insulin aspart 70Administered subcutaneously (s.c., under the skin) at breakfast and lunch | Drug | BIAsp 70 + BIAsp 50 |
| biphasic insulin aspart 50Administered subcutaneously (s.c., under the skin) at dinner | Drug | BIAsp 70 + BIAsp 50 |
Primary outcome
Fasting serum glucose
4 secondary outcomes
24-hour serum glucose profiles
24-hour insulin profiles
Incidence of hypoglycaemic episodes
Incidence 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 14617230Ejskjaer N, Rasmussen M, Kamp N, Lindholm A, Christiansen JS. Comparison of thrice daily 'high' vs. 'medium' premixed insulin aspart with respect to evening and overnight glycaemic control in patients with type 2 diabetes. Diabetes Obes Metab. 2003 Nov;5(6):438-45. doi: 10.1046/j.1463-1326.2003.00299.x.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biphasic insulin aspart 70 and biphasic insulin aspart 50 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Denmark.
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 5 inclusion and 7 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 1 site in Denmark. 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?
Fasting serum glucose. 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 NCT01520753, 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.