Type 2 Diabetes MellitusPhase 4DEESNCT00788840
Detemir Energy Expenditure Study
A Phase 4 study testing Insulatard and Detemir in people with Type 2 Diabetes Mellitus and Obesity, run by University of Surrey at 1 site in United Kingdom.
Trial summary
This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- Insulatard and Detemir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Aug 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Treated with metformin
- Already on treatment with a long-acting or intermediate insulin.
- Over 18 years of age,
- HbA1c > 7.0%
- BMI 27-40
Show all 9Show fewer
- Able and willing to perform self-blood glucose monitoring.
- Able and willing to maintain consistent eating habits throughout the entire trial period.
- Able and willing to maintain consistent physical activity level during the entire trial period
Who cannot join
- Patients on sulphonylureas or thiazolidinediones
- Proliferative retinopathy that has required acute treatment within the last six months.
- Impaired hepatic or renal functions.
- Cardiac problems.
- Uncontrolled hypertension (treated or untreated).
- Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cedar Centre, Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
About this study
Official title: A 24-week, National, Single-centre, Open-labelled, Randomised, Parallel-group Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-bolus Regimen With Insulin Aspart as the Mealtime Insulin in Subjects With Type 2 Diabetes
This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- Insulatard, Detemir
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulatardDrug
Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
DetemirDrug
Also called Levemir
Detemir insulin used as long-acting insulin in treatment phase of study.
| Study group | Role | What they receive |
|---|---|---|
| 1. Insulatard | Active comparator | Not described Receives: Drug: Insulatard |
| 2. Detemir | Active comparator | Not described Receives: Drug: Detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Measured: 6 months
Secondary outcomes (4)
Energy Expenditure
Measured: 6 months
Fat composition
Measured: 6 months
Fat & muscle gene expression
Measured: 6 months
Glycaemic control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionAug 2009
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- David Russell-Jones, MB BS, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788840
- Sponsor's protocol ID
- EC/2008/14/FHMS
- Acronym
- DEES
- Status last verified
- May 2023
- First submitted
- 10 Nov 2008
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PubMed 33166419
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, National, Single-centre, Open-labelled, Randomised, Parallel-group Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-bolus Regimen With Insulin Aspart as the Mealtime Insulin in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00788840
- Acronym / sponsor ID
- DEES / EC/2008/14/FHMS
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jan 2008 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Nov 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.
This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Insulatard | Active comparator | Drug: Insulatard |
| 2. Detemir | Active comparator | Drug: Detemir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type 2 diabetes
- Treated with metformin
- Already on treatment with a long-acting or intermediate insulin.
- Over 18 years of age,
- HbA1c > 7.0%
Key exclusion criteria (6 listed)
- Patients on sulphonylureas or thiazolidinediones
- Proliferative retinopathy that has required acute treatment within the last six months.
- Impaired hepatic or renal functions.
- Cardiac problems.
- Uncontrolled hypertension (treated or untreated).
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 |
|---|---|---|
| InsulatardInsulatard insulin used as long-acting insulin for 16-week treatment phase of study. | Drug | 1. Insulatard |
| DetemirAlso: LevemirDetemir insulin used as long-acting insulin in treatment phase of study. | Drug | 2. Detemir |
Primary outcome
Weight change
Time frame: 6 months
4 secondary outcomes
Energy Expenditure
Time frame: 6 months
Fat composition
Time frame: 6 months
Fat & muscle gene expression
Time frame: 6 months
Glycaemic control
Time frame: 6 months
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 May 2023.
- Derived from this study: PubMed 33166419Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
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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.
David Russell-Jones, MB BS principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulatard and Detemir in people with Type 2 Diabetes Mellitus and Obesity, run by University of Surrey at 1 site in United Kingdom.
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 9 inclusion and 6 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 May 2023. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Weight change (time frame: 6 months). 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 NCT00788840, 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 May 2023.