DiabetesPhase 2NCT01526980
Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes
A Phase 2 study testing biphasic insulin aspart 30, biphasic insulin aspart 70 and biphasic human insulin 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 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 30, 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
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2002to Nov 2002
- Phase
- Phase 2
- 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 Type 2 diabetes
- Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
- HbA1c maximum 10.0%
- BMI (Body Mass Index) maximum 35.0 kg/m2
- Able and willing to perform self-blood glucose monitoring (SBGM)
Who cannot join
- The receipt of any investigational drug within the last 30 days prior to this trial
- Total daily insulin dose minimum 2.0 U/(kg·day)
- A history of drug abuse or alcohol dependence within the last 5 years
- Impaired hepatic function
- Impaired renal function
- Cardiac disease
- Severe, uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30
This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 30, biphasic insulin aspart 70, biphasic human insulin 30
- 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 30Drug
Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
biphasic insulin aspart 70Drug
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
biphasic human insulin 30Drug
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
| Study group | Role | What they receive |
|---|---|---|
| Treatment period 1 | Experimental | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 70; Drug: biphasic human insulin 30 |
| Treatment period 2 | Active comparator | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 70; Drug: biphasic human insulin 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose average in 24-hour blood glucose profiles
Secondary outcomes (6)
Pre-meal glucose level
Post-meal excursion of glucose (0-4 hours)
Cmax, maximum concentration of total insulin
tmax, time of maximum concentration of total insulin
The area under the 24-hour total insulin concentration time curve
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startMay 2002
- Primary completionNov 2002
- Study completionNov 2002
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT01526980
- Sponsor's protocol ID
- BIASP-1319
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2012
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dashora U, Ashwell SG, Home PD. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):680-7. doi: 10.1111/j.1463-1326.2008.01024.x.
PubMed 19527481
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30
- ClinicalTrials.gov ID
- NCT01526980
- Acronym / sponsor ID
- BIASP-1319
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 6 Feb 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 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment period 1 | Experimental | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 70, Drug: biphasic human insulin 30 |
| Treatment period 2 | Active comparator | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 70, 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 (5 listed)
- Subjects with Type 2 diabetes
- Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
- HbA1c maximum 10.0%
- BMI (Body Mass Index) maximum 35.0 kg/m2
- Able and willing to perform self-blood glucose monitoring (SBGM)
Key exclusion criteria (7 listed)
- The receipt of any investigational drug within the last 30 days prior to this trial
- Total daily insulin dose minimum 2.0 U/(kg·day)
- A history of drug abuse or alcohol dependence within the last 5 years
- Impaired hepatic function
- Impaired renal function
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 30Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period | Drug | Treatment period 1, Treatment period 2 |
| biphasic insulin aspart 70Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period | Drug | Treatment period 1, Treatment period 2 |
| biphasic human insulin 30Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period | Drug | Treatment period 1, Treatment period 2 |
Primary outcome
Glucose average in 24-hour blood glucose profiles
6 secondary outcomes
Pre-meal glucose level
Post-meal excursion of glucose (0-4 hours)
Cmax, maximum concentration of total insulin
tmax, time of maximum concentration of total insulin
The area under the 24-hour total insulin concentration time curve
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 5 Jan 2017.
- Results publication: PubMed 19527481Dashora U, Ashwell SG, Home PD. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):680-7. doi: 10.1111/j.1463-1326.2008.01024.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 2 study testing biphasic insulin aspart 30, biphasic insulin aspart 70 and biphasic human insulin 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United Kingdom.
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 5 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Glucose average in 24-hour blood glucose profiles. 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 NCT01526980, 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 5 Jan 2017.