DiabetesNCT00873639
Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin Analogues
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Romania.
Trial summary
This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin aspart and insulin detemir
- How many people
- 417 participants
- Where
- 1 siteRomania
- Study dates
- Apr 2009to Nov 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 1 diabetes patients from diabetes centres who have been deemed appropriate to receive NovoRapid® and Levemir® as new treatment in basal-balus regimen and as part of routine care by the prescribing physician.
Who may be able to join
- Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen
Who cannot join
- Subjects currently being treated with insulin aspart and insulin detemir
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to insulin aspart or to any of the excipients
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients
- Women who are pregnant or have the intention of becoming pregnant within next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania
This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin aspart, insulin detemir
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspartDrug
Also called NovoRapid®, ANA
Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice
insulin detemirDrug
Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin aspart; Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: at 24 weeks from baseline
Secondary outcomes (7)
Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%
Measured: at 12 weeks and 24 weeks of treatment
Change in FPG (glucose variability)
Measured: at 12 weeks and 24 weeks of treatment
Change in PPG (postprandial control)
Measured: at 12 weeks and 24 weeks of treatment
Change in insulin dose and number of injections
Measured: at 12 weeks and 24 weeks of treatment
Change in body weight
Measured: at 12 weeks and 24 weeks of treatment
Change in number of hypoglycaemic events
Measured: at 12 weeks and 24 weeks of treatment
Number of adverse drug reactions (ADR)
Measured: at 12 weeks and 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionNov 2009
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 417 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
- NCT00873639
- Sponsor's protocol ID
- INS-3721
- Status last verified
- Oct 2016
- First submitted
- 31 Mar 2009
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania
- ClinicalTrials.gov ID
- NCT00873639
- Acronym / sponsor ID
- INS-3721
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 Apr 2009 (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 observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin aspart, Drug: insulin detemir |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 1 diabetes patients from diabetes centres who have been deemed appropriate to receive NovoRapid® and Levemir® as new treatment in basal-balus regimen and as part of routine care by the prescribing physician.
Key inclusion criteria (1 listed)
- Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen
Key exclusion criteria (5 listed)
- Subjects currently being treated with insulin aspart and insulin detemir
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to insulin aspart or to any of the excipients
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients
- Women who are pregnant or have the intention of becoming pregnant within next 6 months
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 |
|---|---|---|
| insulin aspartAlso: NovoRapid®, ANAEffectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice | Drug | A |
| insulin detemirEffectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice | Drug | A |
Primary outcome
Change in HbA1c
Time frame: at 24 weeks from baseline
7 secondary outcomes
Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%
Time frame: at 12 weeks and 24 weeks of treatment
Change in FPG (glucose variability)
Time frame: at 12 weeks and 24 weeks of treatment
Change in PPG (postprandial control)
Time frame: at 12 weeks and 24 weeks of treatment
Change in insulin dose and number of injections
Time frame: at 12 weeks and 24 weeks of treatment
Change in body weight
Time frame: at 12 weeks and 24 weeks of treatment
Change in number of hypoglycaemic events
Time frame: at 12 weeks and 24 weeks of treatment
Number of adverse drug reactions (ADR)
Time frame: at 12 weeks and 24 weeks of treatment
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 14 Oct 2016.
- 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?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Romania.
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 1 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 14 Oct 2016. 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 Romania. 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.
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?
Change in HbA1c (time frame: at 24 weeks from baseline). 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 14 Oct 2016.