DiabetesNCT01542489
Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Slovakia.
Trial summary
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir, insulin aspart and human soluble insulin
- How many people
- 480 participants
- Where
- 1 siteSlovakia
- Study dates
- Oct 2006to Apr 2007
- 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: Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue Levemir® in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
Who may be able to join
- Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.
- Being tested
- insulin detemir, insulin aspart, human soluble insulin
- 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.
insulin detemirDrug
Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
insulin aspartDrug
Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
human soluble insulinDrug
Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
| Study group | Role | What they receive |
|---|---|---|
| IDet + IAsp users | Not described Receives: Drug: insulin detemir; Drug: insulin aspart | |
| IDet + HI users | Not described Receives: Drug: insulin detemir; Drug: human soluble insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (glycosylated haemoglobin)
Secondary outcomes (6)
Change in 7-point blood glucose variability
Change in body weight
Insulin dose
Number of injections
Number of hypoglycaemic episodes
Number of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startOct 2006
- Primary completionApr 2007
- Study completionApr 2007
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 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
- NCT01542489
- Sponsor's protocol ID
- NN304-1927
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2012
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Emil Martinka; Improved Glycemic Control and Weight Loss in Slovakian Patients Switching from NPH to Insulin Detemir; 2049-PO; 69th Scientific Sessions (2009); American Diabetes Association
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01542489
- Acronym / sponsor ID
- NN304-1927
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 2 Mar 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 evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDet + IAsp users | – | Drug: insulin detemir, Drug: insulin aspart |
| IDet + HI users | – | Drug: insulin detemir, Drug: human soluble insulin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue Levemir® in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
Key inclusion criteria (1 listed)
- Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
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 detemirPrescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any | Drug | IDet + HI users, IDet + IAsp users |
| insulin aspartPrescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any | Drug | IDet + IAsp users |
| human soluble insulinPrescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any | Drug | IDet + HI users |
Primary outcome
Change in HbA1c (glycosylated haemoglobin)
6 secondary outcomes
Change in 7-point blood glucose variability
Change in body weight
Insulin dose
Number of injections
Number of hypoglycaemic episodes
Number of 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 31 Jan 2017.
- Results publicationEmil Martinka; Improved Glycemic Control and Weight Loss in Slovakian Patients Switching from NPH to Insulin Detemir; 2049-PO; 69th Scientific Sessions (2009); American Diabetes Association
- 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
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 Slovakia.
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 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 31 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 Slovakia. 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 (glycosylated haemoglobin). 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 NCT01542489, 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 31 Jan 2017.