DiabetesPhase 4NCT01697631
Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes
A Phase 4 study testing biphasic insulin aspart 30 and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 12 sites in Poland.
Trial summary
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70. 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 and insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 12 sitesPoland
- Study dates
- 22 Jul 2002to 24 Apr 2003
- Phase
- Phase 4
- 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
- Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
- HbA1c (glycosylated haemoglobin) equal to or below 12%
- Willing and able to perform self blood glucose monitoring (SMBG)
Who cannot join
- History of drug or alcohol dependence
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Previous participation in this trial
- Receipt of any investigational drug within the last month prior to this trial
- Known or suspected allergy to trial products or related products
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Poland12 sites
Novo Nordisk Investigational Site
Bialystok, 15-276
Novo Nordisk Investigational Site
Bytom, 41-902
Novo Nordisk Investigational Site
Kamieniec Ząbkowicki, 57-230
Novo Nordisk Investigational Site
Katowice, 40-053
Novo Nordisk Investigational Site
Krakow, 31-261
Novo Nordisk Investigational Site
Nysa, 48-300
Novo Nordisk Investigational Site
Otwock, 05-400
Novo Nordisk Investigational Site
Radom, 26-600
Novo Nordisk Investigational Site
Ruda Śląska, 41-700
Novo Nordisk Investigational Site
Sosnowiec, 41-200
Novo Nordisk Investigational Site
Warsaw, 01-877
Novo Nordisk Investigational Site
Wroclaw, 50-306
About this study
Official title: Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 30, insulin aspart
- 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) at breakfast and evening main meals
insulin aspartDrug
Administrated subcutaneously (s.c., under the skin) before lunch
| Study group | Role | What they receive |
|---|---|---|
| BIAsp | Experimental | Not described Receives: Drug: biphasic insulin aspart 30 |
| Insulin aspart | Experimental | Not described Receives: Drug: biphasic insulin aspart 30; Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycosylated haemoglobin)
Secondary outcomes (4)
7-point blood glucose profile
Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification
Incidence of adverse events
Hypoglycaemic episodes (minor, major or nocturnal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start22 Jul 2002
- Primary completion24 Apr 2003
- Study completion24 Apr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 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
- NCT01697631
- Sponsor's protocol ID
- BIASP-1409
- Status last verified
- Feb 2017
- First submitted
- 28 Sep 2012
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70
- ClinicalTrials.gov ID
- NCT01697631
- Acronym / sponsor ID
- BIASP-1409
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2002 (actual)
- Primary completion
- 24 Apr 2003 (actual)
- Study completion
- 24 Apr 2003 (actual)
- First posted
- 2 Oct 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 this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIAsp | Experimental | Drug: biphasic insulin aspart 30 |
| Insulin aspart | Experimental | Drug: biphasic insulin aspart 30, Drug: insulin aspart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
- HbA1c (glycosylated haemoglobin) equal to or below 12%
- Willing and able to perform self blood glucose monitoring (SMBG)
Key exclusion criteria (5 listed)
- History of drug or alcohol dependence
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Previous participation in this trial
- Receipt of any investigational drug within the last month prior to this trial
- Known or suspected allergy to trial products or related products
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) at breakfast and evening main meals | Drug | BIAsp, Insulin aspart |
| insulin aspartAdministrated subcutaneously (s.c., under the skin) before lunch | Drug | Insulin aspart |
Primary outcome
HbA1c (glycosylated haemoglobin)
4 secondary outcomes
7-point blood glucose profile
Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification
Incidence of adverse events
Hypoglycaemic episodes (minor, major or nocturnal)
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 24 Feb 2017.
- 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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biphasic insulin aspart 30 and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 12 sites in Poland.
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 5 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2017.