DiabetesPhase 4NCT00593255
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
A Phase 4 study testing soluble human insulin, insulin aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 5 sites in China.
Trial summary
This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- soluble human insulin, insulin aspart and insulin NPH
- How many people
- 220 participants
- Where
- 5 sitesChina
- Study dates
- Jul 2004to Apr 2005
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or 2 diabetes for at least 4 weeks
- Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
- HbA1c: 7.5-13.5%
- Body Mass Index (BMI): 18-35 kg/m2
Who cannot join
- Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
- History of drug abuse or alcohol dependence
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100034
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100101
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100853
Novo Nordisk Investigational Site
Harbin, Heilongjiang, 150001
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics
This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.
- Being tested
- soluble human insulin, insulin aspart, insulin NPH
- 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.
soluble human insulinDrug
insulin aspartDrug
insulin NPHDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hours postprandial plasma glucose (PPPG)
Measured: after 12 weeks of treatment
Secondary outcomes (5)
Percentage of subjects achieving 2-hours PPPG treatment target
Percentage of subjects achieving HbA1c treatment target
HbA1c
Fasting plasma glucose
Hypoglycaemic episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJul 2004
- Primary completionApr 2005
- Study completionApr 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 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
- NCT00593255
- Sponsor's protocol ID
- ANA-1634
- Status last verified
- Dec 2016
- First submitted
- 2 Jan 2008
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gao Y, Pan C, Zou D, Xu Z, Liu X, Guo X. Superior prandial glucose control with Insulin Aspart compared to Regular Human Insulin in Basal Bolus Therapy with NPH in Patients with Inadequately Controlled T1DM or T2DM. ADA 2006 2006; 55 (Suppl. 1): A464 (2005-PO)
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics
- ClinicalTrials.gov ID
- NCT00593255
- Acronym / sponsor ID
- ANA-1634
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 14 Jan 2008 (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 Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or 2 diabetes for at least 4 weeks
- Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
- HbA1c: 7.5-13.5%
- Body Mass Index (BMI): 18-35 kg/m2
Key exclusion criteria (2 listed)
- Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
- History of drug abuse or alcohol dependence
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 |
|---|---|---|
| soluble human insulin | Drug | – |
| insulin aspart | Drug | – |
| insulin NPH | Drug | – |
Primary outcome
2-hours postprandial plasma glucose (PPPG)
Time frame: after 12 weeks of treatment
5 secondary outcomes
Percentage of subjects achieving 2-hours PPPG treatment target
Percentage of subjects achieving HbA1c treatment target
HbA1c
Fasting plasma glucose
Hypoglycaemic episodes
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 22 Dec 2016.
- Results publicationGao Y, Pan C, Zou D, Xu Z, Liu X, Guo X. Superior prandial glucose control with Insulin Aspart compared to Regular Human Insulin in Basal Bolus Therapy with NPH in Patients with Inadequately Controlled T1DM or T2DM. ADA 2006 2006; 55 (Suppl. 1): A464 (2005-PO)
- 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
5 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 soluble human insulin, insulin aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 5 sites in China.
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 2 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 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
2-hours postprandial plasma glucose (PPPG) (time frame: after 12 weeks of treatment). 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 NCT00593255, 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 22 Dec 2016.