Liraglutide and Insulin Therapy in Patients With Type 2 Diabetes (ELEGANT)
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|ClinicalTrials.gov Identifier: NCT01392898|
Recruitment Status : Unknown
Verified July 2011 by Radboud University.
Recruitment status was: Active, not recruiting
First Posted : July 13, 2011
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: liraglutide Drug: Insulin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Liraglutide on Insulin-associated wEight GAiN in Patients With Type 2 Diabetes Mellitus (ELEGANT Trial)|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2014|
liraglutide 1.8 mg q.d.
|Active Comparator: insulin||
insulin dosed according titration scheme
- 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.
- Measuring change in insulin dose (insulin dose at 26 weeks minus insulin dose at baseline) [ Time Frame: 26 weeks (26 weeks -baseline) ]Change in insulin dose by measuring insulin dose at 26 weeks minus the insulin dose at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392898
|Radboud University Nijmegen Medical Centre|