Type 2 Diabetes MellitusELEGANTNCT01392898
Liraglutide and Insulin Therapy in Patients With Type 2 Diabetes
A study testing liraglutide and Insulin in people with Type 2 Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes. Although insulin is an effective treatment modality, this is often at the expense of significant weight gain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- liraglutide and Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to May 2014
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus on short-term insulin therapy (≤ 12 months); all types of insulin allowed
- Documented insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy until inclusion
- Age 18-75 years
- BMI ≥ 25 kg/m2
- Stable glycaemic control mirrored by HbA1c ≥ 6.5 and ≤ 8.5 %
Who cannot join
- Inability to provide informed consent
- Type 1 diabetes mellitus, MODY diabetes, or LADA diabetes (presence of anti-GAD)
- Presence of any medical condition that might interfere with the current study protocol.
- Inflammatory bowel disease (e.g. M. Crohn, ulcerative colitis)
- Recurrent hypoglycaemic events
- Diabetic gastroparesis
Show all 13Show fewer
- Heart failure (LVEF ≤ 30%)
- Use of TZDs (glitazones), DDP-IV (dipeptidylpeptidase-inhibitor)
- Use of medication associated with impaired glucose metabolism including corticosteroids
- Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women)
- Pre-existing thyroid disease
- Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
- Renal disease (creatinine > 130 µmol/l or MDRD-GFR <30 ml/min/1.73m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Liraglutide on Insulin-associated wEight GAiN in Patients With Type 2 Diabetes Mellitus (ELEGANT Trial)
Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes. Although insulin is an effective treatment modality, this is often at the expense of significant weight gain. Weight gain is obviously undesirable in an already overweight population, but may also deter further optimization of insulin therapy. Large inter-individual differences exist in the level of weight gain after initiation of insulin therapy, but no clear predictive factors have prospectively been identified thus far.
Liraglutide (Victoza®), a human glucagon-like peptide-1 (GLP-1) analogue, improves glycaemic control and reduces weight. We hypothesize that in patients who show (excessive) weight gain after introducing insulin therapy, adding liraglutide is effective in reversing body weight while preserving glycaemic control.
Read the detailed description
Patients with type 2 diabetes mellitus on short-term (≤ 12 months) insulin therapy with concomitant documented weight gain of ≥ 4 % body weight will be selected and treated with liraglutide 1.8 mg sc q.d. for 26 weeks and compared to patients receiving standard care (continuation of insulin therapy without liraglutide) in an open-label, randomized study. After 26 weeks, patients receiving standard care will subsequently be treated with liraglutide for 26 weeks. The group on active liraglutide treatment will continue for an additional 26 weeks. In this way all patients can benefit from liraglutide.
All subjects will continue insulin therapy and oral hypoglycaemic agents (SU derivatives and metformin allowed) treatment. With respect to safety in order to avoid hypoglycaemic events, total insulin dose will be decreased by 20% when starting liraglutide. Within the first weeks after start of study medication patients will perform frequently self-measured capillary blood glucose profiles and will be instructed to adjust insulin dose if necessary. Initially, insulin dose will be adjusted weekly by telephone consultation. Thereafter, patients will perform blood glucose profiles prior to every outpatient visit. A liraglutide-insulin titration algorithm will be used to adjust insulin dose. Every 4-6 weeks patients will visit the hospital to assess body weight, to adjust insulin dose and to check for adverse events.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- liraglutide, Insulin
- Keywords
- liraglutide, insulin, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
liraglutide 1.8 mg q.d.
InsulinDrug
insulin dosed according titration scheme
| Study group | Role | What they receive |
|---|---|---|
| liraglutide | Experimental | Not described Receives: Drug: liraglutide |
| insulin | Active comparator | Not described Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change (measured body weight at 26 weeks minus baseline body weight)
Measuring body weight after 26 weeks minus baseline body weight as the change in body weight after Liraglutide treatment.
Measured: 26 weeks (26 weeks - baseline)
Secondary outcomes (1)
Measuring change in insulin dose (insulin dose at 26 weeks minus insulin dose at baseline)
Change in insulin dose by measuring insulin dose at 26 weeks minus the insulin dose at baseline.
Measured: 26 weeks (26 weeks -baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startFeb 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
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.
- More trials run by Radboud University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392898
- Sponsor's protocol ID
- Lir-HJCJ-03
- Acronym
- ELEGANT
- Status last verified
- Jul 2011
- First submitted
- 4 Jul 2011
- Last updated
- 2 Aug 2013
- Results posted
- No
Publications
de Wit HM, Vervoort GM, Jansen HJ, de Grauw WJ, de Galan BE, Tack CJ. Liraglutide reverses pronounced insulin-associated weight gain, improves glycaemic control and decreases insulin dose in patients with type 2 diabetes: a 26 week, randomised clinical trial (ELEGANT). Diabetologia. 2014 Sep;57(9):1812-9. doi: 10.1007/s00125-014-3302-0. Epub 2014 Jun 20.
PubMed 24947583
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liraglutide on Insulin-associated wEight GAiN in Patients With Type 2 Diabetes Mellitus (ELEGANT Trial)
- ClinicalTrials.gov ID
- NCT01392898
- Acronym / sponsor ID
- ELEGANT / Lir-HJCJ-03
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- liraglutide, insulin, type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 13 Jul 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.
Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes. Although insulin is an effective treatment modality, this is often at the expense of significant weight gain. Weight gain is obviously undesirable in an already overweight population, but may also deter further optimization of insulin therapy. Large inter-individual differences exist in the level of weight gain after initiation of insulin therapy, but no clear predictive factors have prospectively been identified thus far.
Liraglutide (Victoza®), a human glucagon-like peptide-1 (GLP-1) analogue, improves glycaemic control and reduces weight. We hypothesize that in patients who show (excessive) weight gain after introducing insulin therapy, adding liraglutide is effective in reversing body weight while preserving glycaemic control.
Detailed description
Patients with type 2 diabetes mellitus on short-term (≤ 12 months) insulin therapy with concomitant documented weight gain of ≥ 4 % body weight will be selected and treated with liraglutide 1.8 mg sc q.d. for 26 weeks and compared to patients receiving standard care (continuation of insulin therapy without liraglutide) in an open-label, randomized study. After 26 weeks, patients receiving standard care will subsequently be treated with liraglutide for 26 weeks. The group on active liraglutide treatment will continue for an additional 26 weeks. In this way all patients can benefit from liraglutide.
All subjects will continue insulin therapy and oral hypoglycaemic agents (SU derivatives and metformin allowed) treatment. With respect to safety in order to avoid hypoglycaemic events, total insulin dose will be decreased by 20% when starting liraglutide. Within the first weeks after start of study medication patients will perform frequently self-measured capillary blood glucose profiles and will be instructed to adjust insulin dose if necessary. Initially, insulin dose will be adjusted weekly by telephone consultation. Thereafter, patients will perform blood glucose profiles prior to every outpatient visit. A liraglutide-insulin titration algorithm will be used to adjust insulin dose. Every 4-6 weeks patients will visit the hospital to assess body weight, to adjust insulin dose and to check for adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liraglutide | Experimental | Drug: liraglutide |
| insulin | Active comparator | Drug: Insulin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type 2 diabetes mellitus on short-term insulin therapy (≤ 12 months); all types of insulin allowed
- Documented insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy until inclusion
- Age 18-75 years
- BMI ≥ 25 kg/m2
- Stable glycaemic control mirrored by HbA1c ≥ 6.5 and ≤ 8.5 %
Key exclusion criteria (13 listed)
- Inability to provide informed consent
- Type 1 diabetes mellitus, MODY diabetes, or LADA diabetes (presence of anti-GAD)
- Presence of any medical condition that might interfere with the current study protocol.
- Inflammatory bowel disease (e.g. M. Crohn, ulcerative colitis)
- Recurrent hypoglycaemic events
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 |
|---|---|---|
| liraglutideliraglutide 1.8 mg q.d. | Drug | liraglutide |
| Insulininsulin dosed according titration scheme | Drug | insulin |
Primary outcome
Body weight change (measured body weight at 26 weeks minus baseline body weight)
Time frame: 26 weeks (26 weeks - baseline)
Measuring body weight after 26 weeks minus baseline body weight as the change in body weight after Liraglutide treatment.
1 secondary outcome
Measuring change in insulin dose (insulin dose at 26 weeks minus insulin dose at baseline)
Time frame: 26 weeks (26 weeks -baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Derived from this study: PubMed 24947583de Wit HM, Vervoort GM, Jansen HJ, de Grauw WJ, de Galan BE, Tack CJ. Liraglutide reverses pronounced insulin-associated weight gain, improves glycaemic control and decreases insulin dose in patients with type 2 diabetes: a 26 week, randomised clinical trial (ELEGANT). Diabetologia. 2014 Sep;57(9):1812-9. doi: 10.1007/s00125-014-3302-0. Epub 2014 Jun 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liraglutide and Insulin in people with Type 2 Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.
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 13 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: status not confirmed, as of the sponsor's last update on 2 Aug 2013. 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 Netherlands. 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?
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?
Body weight change (measured body weight at 26 weeks minus baseline body weight) (time frame: 26 weeks (26 weeks - baseline)). 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 NCT01392898, 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 2 Aug 2013.