DiabetesNCT01487421
An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin aspart and insulin detemir
- Type of treatment
- Injection or infusion
- How many people
- 2,134 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2003to Oct 2006
- 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: Patients with insufficiently controlled type 2 diabetes mellitus treated with diet, OAD (oral anti-diabetes drug), long acting insulin, premixed insulin or a combination
Who may be able to join
- Type 2 diabetes
- OAD monotherapy
- OAD combination therapy
- Therapy with OAD and basal insulin
- Conventional insulin therapy with premixed insulin
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed
This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin aspart, insulin detemir
- 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.
insulin aspartDrug
Subjects were observed over a time period of 12 weeks after initiation of a supplementary insulin therapy regimen (SIT) with insulin aspart at mealtimes. Administrated subcutaneously (s.c., under the skin)
insulin detemirDrug
Insulin detemir were added to insulin aspart in the evening or at bedtime, if needed. Administrated subcutaneously (s.c., under the skin)
| Study group | Role | What they receive |
|---|---|---|
| SIT | 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.
HbA1c (glycosylated haemoglobin)
Secondary outcomes (5)
Fasting blood glucose (FBG)
2-hours postprandial blood glucose
Hypoglycemia
Weight development
Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJul 2003
- Primary completionOct 2006
- Study completionOct 2006
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
- 2,134 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
- NCT01487421
- Sponsor's protocol ID
- ANA-1934
- Status last verified
- Jun 2014
- First submitted
- 25 Nov 2011
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed
- ClinicalTrials.gov ID
- NCT01487421
- Acronym / sponsor ID
- ANA-1934
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,134 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 7 Dec 2011 (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 study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIT | – | Drug: insulin aspart, Drug: insulin detemir |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with insufficiently controlled type 2 diabetes mellitus treated with diet, OAD (oral anti-diabetes drug), long acting insulin, premixed insulin or a combination
Key inclusion criteria (5 listed)
- Type 2 diabetes
- OAD monotherapy
- OAD combination therapy
- Therapy with OAD and basal insulin
- Conventional insulin therapy with premixed insulin
Key exclusion criteria (0 listed)
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 aspartSubjects were observed over a time period of 12 weeks after initiation of a supplementary insulin therapy regimen (SIT) with insulin aspart at mealtimes. Administrated subcutaneously (s.c., under the skin) | Drug | SIT |
| insulin detemirInsulin detemir were added to insulin aspart in the evening or at bedtime, if needed. Administrated subcutaneously (s.c., under the skin) | Drug | SIT |
Primary outcome
HbA1c (glycosylated haemoglobin)
5 secondary outcomes
Fasting blood glucose (FBG)
2-hours postprandial blood glucose
Hypoglycemia
Weight development
Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs)
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 Jun 2014.
- 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 2, run by Novo Nordisk A/S at 1 site in Germany.
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 0 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 Jun 2014. 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 Germany. 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?
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 Jun 2014.