DiabetesKILOSNCT00849342
Observational Study on Levemir® in Obese Diabetic Patients
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir
- How many people
- 580 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2008to Jan 2013
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® because of weight increase on other insulin therapies, and as part of routine out-patient care by the prescribing physician.
Who may be able to join
- Diabetes mellitus (Type 1 or type 2)
- BMI greater than 27 kg/m^2, or more than 3 kg weight increase since start of insulin therapy
Who cannot join
- Subjects currently being treated with insulin detemir
- Subjects who were previously enrolled in this study;
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins
This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients.
Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.
- Being tested
- insulin detemir
- 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
Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight and BMI
Measured: during 12 months of treatment
Secondary outcomes (7)
Change in body weight at different BMI subgroups
Measured: at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment
Change in waist perimeter
Measured: from insulin start and after 6 and 12 months of treatment
Change in FPG (Fasting Plasma Glucose)
Measured: from 12 and 6 months before treatment after 6 and 12 months of treatment
Change in HbA1C
Measured: from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment
Change in number of hypoglycaemic events during 4 weeks proceeding routine visits
Measured: after 6 and 12 months of treatment
Number of adverse drug reactions (ADR)
Measured: after 6 and 12 months of treatment
Change in blood pressure
Measured: from insulin start and 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionJan 2013
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 580 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
- NCT00849342
- Sponsor's protocol ID
- NN304-3708
- Acronym
- KILOS
- Status last verified
- Jul 2014
- First submitted
- 20 Feb 2009
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins
- ClinicalTrials.gov ID
- NCT00849342
- Acronym / sponsor ID
- KILOS / NN304-3708
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Feb 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 study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients.
Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin detemir |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® because of weight increase on other insulin therapies, and as part of routine out-patient care by the prescribing physician.
Key inclusion criteria (2 listed)
- Diabetes mellitus (Type 1 or type 2)
- BMI greater than 27 kg/m^2, or more than 3 kg weight increase since start of insulin therapy
Key exclusion criteria (4 listed)
- Subjects currently being treated with insulin detemir
- Subjects who were previously enrolled in this study;
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.
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 detemirSafety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice. | Drug | A |
Primary outcome
Change in body weight and BMI
Time frame: during 12 months of treatment
7 secondary outcomes
Change in body weight at different BMI subgroups
Time frame: at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment
Change in waist perimeter
Time frame: from insulin start and after 6 and 12 months of treatment
Change in FPG (Fasting Plasma Glucose)
Time frame: from 12 and 6 months before treatment after 6 and 12 months of treatment
Change in HbA1C
Time frame: from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment
Change in number of hypoglycaemic events during 4 weeks proceeding routine visits
Time frame: after 6 and 12 months of treatment
Number of adverse drug reactions (ADR)
Time frame: after 6 and 12 months of treatment
Change in blood pressure
Time frame: from insulin start and 6 and 12 months after 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 15 Aug 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
2 sites in 2 countries: 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 2 sites in 2 countries.
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 2 inclusion and 4 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Slovenia. 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 body weight and BMI (time frame: during 12 months of treatment). 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 15 Aug 2014.