DiabetesPhase 3NCT00656422
Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine
A Phase 3 study testing insulin Levemir and insulin Lantus in people with Diabetes and Obesity, run by University Hospital Tuebingen at 5 sites in 3 countries.
Trial summary
The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- insulin Levemir and insulin Lantus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Nov 2007to not given
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 80 years
- Gender: female, male
- Type 2 diabetes
- BMI: 20.0 - 38.0
- Anti-GAD antibody negative
- Fasting blood glucose > 126 mg/dl
- HbA1c 7.0 - 11.0%
- Need for insulin therapy
Who cannot join
- Previous therapy with insulin within the last 3 months prior to inclusion into the study
- Previous therapy with glitazones within the last 6 months prior to inclusion into the study
- Change in therapy with lipid-lowering or anti-hypertensive agent within one month prior to inclusion into the study (a stable lipid-lowering or anti-hypertensive therapy is allowed)
- Concomitant participation in other clinical trials
- Type 1 diabetes
- Cardiac and macrovascular disease
Show all 19Show fewer
- Malignancy including leukaemia and lymphoma within the last 5 years
- Liver disease: cirrhosis or chronic active hepatitis, except fat liver
- Significant renal dysfunction
- other Endocrine disease
- significant laboratory abnormalities
- History of active substance abuse (including an average alcohol consume of > 40g/day and drugs) within the past 2 years
- Female patients: Pregnancy or childbearing potential without adequate contraception (for male patients contraception is not considered as medically important)
- Present therapy with systemic steroids
- Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s
- Use of anti-obesity drugs 3 months prior or during the trial
- Potentially unreliable subjects, probably non compliant subjects, and those judged by the investigator to be unsuitable for the study
- Contraindications for MRI scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia
- Known hypersensitivity to insulin detemir, insulin glargine or to any of the other components
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Austria3 sites
Medical University Graz
Graz, 8036
University Hospital Graz
Graz, 8036
Medical University Vienna
Vienna, 1090
About this study
The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.
- Being tested
- insulin Levemir, insulin Lantus
- Keywords
- insulin therapy, hepatic fat, type 2 diabetes, body composition, comparison of insulin detemir and insulin glargine, Changes in Hepatic Fat, Obesity
- Medical subject headings
- Diabetes Mellitus, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin LevemirDrug
The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
insulin LantusDrug
The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.
| Study group | Role | What they receive |
|---|---|---|
| insulin Levemir | Experimental | Not described Receives: Drug: insulin Levemir |
| insulin Lantus | Experimental | Not described Receives: Drug: insulin Lantus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe changes in hepatic fat content between groups.
Measured: week 26, week 52
Secondary outcomes (9)
To describe the weight changes from baseline to month 12 between the groups following a subcutaneous treatment strategy with either insulin detemir or insulin glargine.
Measured: week 26, week 52
To evaluate changes in body fat and visceral adipose tissue between groups.
Measured: week 26, week 52
To describe changes in waist and hip circumferences between groups.
Measured: weel 26, week 52
To describe changes in eating behavior and food selection between groups.
Measured: week 26, week 52
To describe changes in well being and disease perception between groups.
Measured: week 26, week 52
To evaluate the daily insulin dose between groups.
Measured: 1 year
To describe the fasting blood glucose between groups.
Measured: 1 year
To evaluate hypoglycaemia between groups.
Measured: 1 year
To evaluate safety between groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startNov 2007
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 University Hospital TuebingenThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, University of Bern, CenTrial GmbH
- Investigators
- Andreas Fritsche, Prof. Dr., Principal investigator, University Hospital TuebingenHermann Toplak, Prof. Dr., Principal investigator, Universitäts-Frauenklinik GrazPeter Diem, Prof. Dr., Study chair, Bern University HospitalAlexandra Kautzky-Willer, Prof. Dr., Study chair, Medical University of ViennaThomas Pieber, Univ. Prof. Dr., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656422
- Sponsor's protocol ID
- N-ISP-1
- Other IDs
- LEV-002
- Status last verified
- Oct 2012
- First submitted
- 4 Apr 2008
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine
- ClinicalTrials.gov ID
- NCT00656422
- Acronym / sponsor ID
- N-ISP-1
- Keywords
- insulin therapy, hepatic fat, type 2 diabetes, body composition, comparison of insulin detemir and insulin glargine, Changes in Hepatic Fat, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Medical University of Vienna, University of Bern, CenTrial GmbH
- Study start
- Nov 2007
- First posted
- 11 Apr 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.
The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin Levemir | Experimental | Drug: insulin Levemir |
| insulin Lantus | Experimental | Drug: insulin Lantus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years and < 80 years
- Gender: female, male
- Type 2 diabetes
- BMI: 20.0 - 38.0
- Anti-GAD antibody negative
Key exclusion criteria (19 listed)
- Previous therapy with insulin within the last 3 months prior to inclusion into the study
- Previous therapy with glitazones within the last 6 months prior to inclusion into the study
- Change in therapy with lipid-lowering or anti-hypertensive agent within one month prior to inclusion into the study (a stable lipid-lowering or anti-hypertensive therapy is allowed)
- Concomitant participation in other clinical trials
- Type 1 diabetes
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 LevemirThe participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm. | Drug | insulin Levemir |
| insulin LantusThe participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm. | Drug | insulin Lantus |
Primary outcome
To describe changes in hepatic fat content between groups.
Time frame: week 26, week 52
9 secondary outcomes
To describe the weight changes from baseline to month 12 between the groups following a subcutaneous treatment strategy with either insulin detemir or insulin glargine.
Time frame: week 26, week 52
To evaluate changes in body fat and visceral adipose tissue between groups.
Time frame: week 26, week 52
To describe changes in waist and hip circumferences between groups.
Time frame: weel 26, week 52
To describe changes in eating behavior and food selection between groups.
Time frame: week 26, week 52
To describe changes in well being and disease perception between groups.
Time frame: week 26, week 52
To evaluate the daily insulin dose between groups.
Time frame: 1 year
To describe the fasting blood glucose between groups.
Time frame: 1 year
To evaluate hypoglycaemia between groups.
Time frame: 1 year
To evaluate safety between groups.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
Related trials for Diabetes
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
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.
Andreas Fritsche, Prof. Dr. principal investigator
University Hospital Tuebingen
Hermann Toplak, Prof. Dr. principal investigator
Universitäts-Frauenklinik Graz
Peter Diem, Prof. Dr. study chair
Bern University Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin Levemir and insulin Lantus in people with Diabetes and Obesity, run by University Hospital Tuebingen at 5 sites in 3 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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 1 Nov 2012. 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 Austria, Germany, Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
To describe changes in hepatic fat content between groups. (time frame: week 26, week 52). 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 1 Nov 2012.